Sleep Apnea, Obstructive
Conditions
Brief summary
Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index \>5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.
Detailed description
The participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index \>5/h), and the physician will explain the treatment programs to every subject. By their willingness to choose the therapeutic method, the participants who select the surgery interventions will be assign to TORS or TORS+OPR group. The matched controls as well as age-, sex-, and body mass index-matched OSA participants will be selected from the patients who are waiting for oral appliance, losing weight and using continuous positive airway pressure. Before surgery, 6 week and 18 week after surgery, the investiagters will compare the polysomnography data, questionnaires of sleep quality, drug-induced sleep endoscopy and computed tomography as primary outcomes. The investigators will also compare the tongue and jaw-opening muscle strength and biomarkers of oxidative stress, anti-oxidative stress, inflammatory cytokines and matrix metalloproteinases 9 as secondary outcomes. The OPR would begin at 6 week after surgery, and participants will undergo three months of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, participants will be interviewed one time per week for adjusting the treatment intensity.
Interventions
PROCEDUREtransoral robotic surgery
transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
DEVICEoral appliance
It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
DEVICEusing continuous positive airway pressure
The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
BEHAVIORALlosing weights
The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
COMBINATION_PRODUCToropharyngeal rehabilitation
OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of mild to severe OSA in the past year * Age between 20-65 years old.
Exclusion criteria
* A history of malignancy or infection of the head and neck region and laryngeal trauma * Craniofacial malformation * Stroke * Neuromuscular disease * Heart failure * Coronary artery disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | through study completion, an average of 6 months | Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome. |
| Computer Tomography (CT)_Volume | through study completion, an average of 6 months | All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured. |
| Computer Tomography (CT)_minimal Area | through study completion, an average of 6 months | All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured. |
| Computer Tomography (CT)_AP Distance | through study completion, an average of 6 months | All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured. |
| Computer Tomography (CT)_Lateral Distance | through study completion, an average of 6 months | All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Lateral distance on the tip of epiglottis was measured. |
| Drug-induced Sleep Endoscopy (DISE) | through study completion, an average of 6 months | All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (\<50%); 1: partial obstruction (50-75%); 2: complete obstruction (\>75%). |
| Jaw Opening Muscle Strength | through study completion, an average of 6 months | Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression. |
| Tongue Protrusion Muscle Strength | through study completion, an average of 6 months | The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). |
| Tongue Elevation Muscle Strength | through study completion, an average of 6 months | The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). |
| Tongue Depression Muscle Strength | through study completion, an average of 6 months | The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). |
| Tongue Lateralization Muscle Strength | through study completion, an average of 6 months | The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). |
Countries
Taiwan
Participant flow
Recruitment details
Recruited time:2020/01/01-2022/05/11
Participants by arm
| Arm | Count |
|---|---|
| Control Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.
oral appliance: It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressure: The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weights: The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries. | 20 |
| Transoral Robotic Surgery (TORS) The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study | 42 |
| TORS+OPR The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.
transoral robotic surgery: transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oropharyngeal rehabilitation: OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist. | 19 |
| Total | 81 |
Baseline characteristics
| Characteristic | Control | Transoral Robotic Surgery (TORS) | TORS+OPR | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 42 Participants | 19 Participants | 81 Participants |
| Age, Continuous | 44.25 years STANDARD_DEVIATION 9.55 | 43.12 years STANDARD_DEVIATION 10.87 | 45.10 years STANDARD_DEVIATION 8.63 | 43.91 years STANDARD_DEVIATION 9.93 |
| Body mass index | 27.11 kg/m^2 STANDARD_DEVIATION 3.48 | 28.09 kg/m^2 STANDARD_DEVIATION 3.72 | 27.31 kg/m^2 STANDARD_DEVIATION 4.18 | 27.62 kg/m^2 STANDARD_DEVIATION 3.76 |
| Computed Tomography_ AP distance | 1.72 cm STANDARD_DEVIATION 0.77 | 1.70 cm STANDARD_DEVIATION 0.49 | 1.66 cm STANDARD_DEVIATION 0.4 | 1.69 cm STANDARD_DEVIATION 0.55 |
| Computed Tomography_ lateral distance distance | 3.02 cm STANDARD_DEVIATION 0.84 | 3.30 cm STANDARD_DEVIATION 0.74 | 3.22 cm STANDARD_DEVIATION 0.51 | 3.20 cm STANDARD_DEVIATION 0.71 |
| Computed Tomography_ minimal area | 3.71 cm^2 STANDARD_DEVIATION 1.94 | 3.88 cm^2 STANDARD_DEVIATION 1.44 | 3.54 cm^2 STANDARD_DEVIATION 1.38 | 3.74 cm^2 STANDARD_DEVIATION 1.55 |
| Computed Tomography_ Volume | 19.04 cm^3 STANDARD_DEVIATION 11.4 | 19.33 cm^3 STANDARD_DEVIATION 8.67 | 16.80 cm^3 STANDARD_DEVIATION 6.07 | 18.56 cm^3 STANDARD_DEVIATION 8.82 |
| Drug-induced sleep endoscopy | 20 Participants | 42 Participants | 19 Participants | 81 Participants |
| Jaw opening muscle strength | 8.97 kg STANDARD_DEVIATION 3.7 | 9.70 kg STANDARD_DEVIATION 3.87 | 9.84 kg STANDARD_DEVIATION 2.52 | 9.55 kg STANDARD_DEVIATION 3.47 |
| Neck circumference | 37.81 cm STANDARD_DEVIATION 2.53 | 39.38 cm STANDARD_DEVIATION 3.48 | 39.53 cm STANDARD_DEVIATION 2.08 | 39.00 cm STANDARD_DEVIATION 2.98 |
| Polysomonography | 38.39 events per hour STANDARD_DEVIATION 22.15 | 43.98 events per hour STANDARD_DEVIATION 19.86 | 45.43 events per hour STANDARD_DEVIATION 21.71 | 42.92 events per hour STANDARD_DEVIATION 20.86 |
| Race/Ethnicity, Customized Asian | 20 Participants | 42 Participants | 19 Participants | 81 Participants |
| Region of Enrollment Taiwan | 20 Participants | 42 Participants | 19 Participants | 81 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 37 Participants | 18 Participants | 70 Participants |
| Tongue depression muscle strength | 43.56 kPa STANDARD_DEVIATION 10.19 | 47.16 kPa STANDARD_DEVIATION 11.04 | 40.95 kPa STANDARD_DEVIATION 10.86 | 44.51 kPa STANDARD_DEVIATION 10.95 |
| Tongue elevation muscle strength | 52.50 kPa STANDARD_DEVIATION 14.13 | 58.25 kPa STANDARD_DEVIATION 15.25 | 50.47 kPa STANDARD_DEVIATION 10.52 | 54.61 kPa STANDARD_DEVIATION 14.05 |
| Tongue lateralization muscle strength | 35.72 kPa STANDARD_DEVIATION 9.98 | 42.20 kPa STANDARD_DEVIATION 11.81 | 41.79 kPa STANDARD_DEVIATION 11.45 | 40.40 kPa STANDARD_DEVIATION 11.44 |
| Tongue protrusion muscle strength | 52.50 kPa STANDARD_DEVIATION 12.82 | 61.16 kPa STANDARD_DEVIATION 16.94 | 51.00 kPa STANDARD_DEVIATION 15.87 | 56.10 kPa STANDARD_DEVIATION 16.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 42 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 42 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 42 | 0 / 19 |
Outcome results
Primary
Apnea Hypopnea Index (AHI)
Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Apnea Hypopnea Index (AHI) | 44.89 events per hour | Standard Deviation 21.09 |
| Transoral Robotic Surgery (TORS) | Apnea Hypopnea Index (AHI) | 44.65 events per hour | Standard Deviation 19.91 |
| TORS+OPR | Apnea Hypopnea Index (AHI) | 36.87 events per hour | Standard Deviation 21.87 |
Comparison: We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~.p-value: <0.05Regression, Linear
Primary
Computer Tomography (CT)_AP Distance
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Computer Tomography (CT)_AP Distance | 1.71 cm | Standard Deviation 0.79 |
| Transoral Robotic Surgery (TORS) | Computer Tomography (CT)_AP Distance | 1.64 cm | Standard Deviation 0.39 |
| TORS+OPR | Computer Tomography (CT)_AP Distance | 1.66 cm | Standard Deviation 0.4 |
Comparison: We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Computer Tomography (CT)_Lateral Distance
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Lateral distance on the tip of epiglottis was measured.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Computer Tomography (CT)_Lateral Distance | 2.92 cm | Standard Deviation 0.83 |
| Transoral Robotic Surgery (TORS) | Computer Tomography (CT)_Lateral Distance | 3.43 cm | Standard Deviation 0.63 |
| TORS+OPR | Computer Tomography (CT)_Lateral Distance | 3.22 cm | Standard Deviation 0.51 |
Comparison: We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Computer Tomography (CT)_minimal Area
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Computer Tomography (CT)_minimal Area | 3.60 cm^2 | Standard Deviation 1.94 |
| Transoral Robotic Surgery (TORS) | Computer Tomography (CT)_minimal Area | 3.80 cm^2 | Standard Deviation 1.13 |
| TORS+OPR | Computer Tomography (CT)_minimal Area | 3.54 cm^2 | Standard Deviation 1.38 |
Comparison: We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)p-value: <0.05Regression, Linear
Primary
Computer Tomography (CT)_Volume
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Computer Tomography (CT)_Volume | 18.39 cm^3 | Standard Deviation 11.47 |
| Transoral Robotic Surgery (TORS) | Computer Tomography (CT)_Volume | 18.72 cm^3 | Standard Deviation 6.43 |
| TORS+OPR | Computer Tomography (CT)_Volume | 16.80 cm^3 | Standard Deviation 6.07 |
Comparison: We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Drug-induced Sleep Endoscopy (DISE)
All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (\<50%); 1: partial obstruction (50-75%); 2: complete obstruction (\>75%).
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | no obstruction | 0 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | no obstruction | 2 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | partial obstruction | 9 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | complete obstruction | 10 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | partial obstruction | 13 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | no obstruction | 0 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | partial obstruction | 7 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | complete obstruction | 2 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | complete obstruction | 11 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | complete obstruction | 8 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | partial obstruction | 6 Participants |
| Control | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | no obstruction | 0 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | complete obstruction | 8 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | complete obstruction | 20 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | no obstruction | 0 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | partial obstruction | 6 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | complete obstruction | 32 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | no obstruction | 2 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | partial obstruction | 28 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | partial obstruction | 16 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | complete obstruction | 22 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | no obstruction | 0 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | partial obstruction | 18 Participants |
| Transoral Robotic Surgery (TORS) | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | no obstruction | 0 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | no obstruction | 1 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | partial obstruction | 11 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | complete obstruction | 9 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | complete obstruction | 11 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | partial obstruction | 7 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | no obstruction | 0 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | complete obstruction | 5 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in epiglottis | complete obstruction | 8 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | no obstruction | 1 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in oropharynx | partial obstruction | 13 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in velum | no obstruction | 1 Participants |
| TORS+OPR | Drug-induced Sleep Endoscopy (DISE) | The degree of obstruction in tongue base | partial obstruction | 9 Participants |
Comparison: We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).p-value: <0.05Fisher Exact
Primary
Jaw Opening Muscle Strength
Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Jaw Opening Muscle Strength | 9.14 kilogram force | Standard Deviation 3.67 |
| Transoral Robotic Surgery (TORS) | Jaw Opening Muscle Strength | 9.63 kilogram force | Standard Deviation 3.59 |
| TORS+OPR | Jaw Opening Muscle Strength | 9.68 kilogram force | Standard Deviation 2.49 |
Comparison: We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Tongue Depression Muscle Strength
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Tongue Depression Muscle Strength | 49.94 kilopascals | Standard Deviation 10.22 |
| Transoral Robotic Surgery (TORS) | Tongue Depression Muscle Strength | 48.22 kilopascals | Standard Deviation 10.38 |
| TORS+OPR | Tongue Depression Muscle Strength | 58.58 kilopascals | Standard Deviation 9.16 |
Comparison: We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Tongue Elevation Muscle Strength
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Tongue Elevation Muscle Strength | 59.17 kilopascals | Standard Deviation 13.64 |
| Transoral Robotic Surgery (TORS) | Tongue Elevation Muscle Strength | 57.22 kilopascals | Standard Deviation 12.59 |
| TORS+OPR | Tongue Elevation Muscle Strength | 63.37 kilopascals | Standard Deviation 12.07 |
Comparison: We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Tongue Lateralization Muscle Strength
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Tongue Lateralization Muscle Strength | 42.19 kilopascals | Standard Deviation 10.52 |
| Transoral Robotic Surgery (TORS) | Tongue Lateralization Muscle Strength | 41.55 kilopascals | Standard Deviation 9.86 |
| TORS+OPR | Tongue Lateralization Muscle Strength | 50.11 kilopascals | Standard Deviation 9.38 |
Comparison: We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear
Primary
Tongue Protrusion Muscle Strength
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Time frame: through study completion, an average of 6 months
Population: Seven participants didn't complete the whole protocol, so we didn't analyze their data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Tongue Protrusion Muscle Strength | 57.83 kilopascals | Standard Deviation 11.17 |
| Transoral Robotic Surgery (TORS) | Tongue Protrusion Muscle Strength | 56.97 kilopascals | Standard Deviation 11.72 |
| TORS+OPR | Tongue Protrusion Muscle Strength | 61.89 kilopascals | Standard Deviation 8.88 |
Comparison: We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).p-value: <0.05Regression, Linear