Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, tongue suspension
Brief summary
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
Detailed description
Obstructive sleep apnea (OSA) has become a major health problem in the United States. With prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure. The first and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients exhibit long-term compliance with CPAP. It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact there are many surgical procedures performed currently to address tongue based collapse. These include RF ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension. The current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.
Interventions
DEVICEEncore Tongue Suspension System
The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Sponsors
Siesta Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure * Age \>/= 20 and \>/= 65 * Body Mass Index ,/= 32 (kg/m\^2) * Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP * Signed informed consent to participate in this study
Exclusion criteria
* Prior OSA surgery * Active systemic infection * Allergy to any medication used during implantation * Previous history of neck or upper respiratory tract * Significant dysphagia or speech disorder Anatomical * Identified obvious palatal stenosis * Enlarged tonsils (3+) * Anatomy unable to accommodate the implant Other * Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment * Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study * Unable and/or not willing to comply with treatment follow-up requirements * Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Place the Implant and Stabilize the Tongue | Up to 7 weeks after the procedure | Ability to place the implant and stabilize the tongue |
| Number of Participants Experiencing Complications | 3 months | Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | Baseline, 3, and 12 months | 0 to \>30/hour (high value represents worse outcome) |
| Functional Outcomes and Sleep Questionnaire (FOSQ) | Baseline, 1, 3, 12 months | Questionnaire: 0 to 120 (high value represents better outcome) |
| Snoring Scale (VAS) | Baseline, 1 week; 1 month, 3 months, 12 months | 0 to 10 (high value represents worse outcome) |
| Epworth Sleeping Scale (ESS) | Baseline, 1, 3, 12 months | 0 to 24 (high value represents worse outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tongue Suspension Tongue-based suspension
Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Tongue Suspension |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Body Mass Index (BMI) | 26.98 kg/m^2 STANDARD_DEVIATION 3.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 1 Participants |
| Gender Male | 4 Participants |
| Prior OSA Surgery | 5 Participants |
| Region of Enrollment United States | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants Experiencing Complications
Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tongue Suspension | Number of Participants Experiencing Complications | Headache | 1 Participants |
| Tongue Suspension | Number of Participants Experiencing Complications | No Complications | 4 Participants |
Primary
Place the Implant and Stabilize the Tongue
Ability to place the implant and stabilize the tongue
Time frame: Up to 7 weeks after the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tongue Suspension | Place the Implant and Stabilize the Tongue | 5 Participants |
Secondary
Apnea Hypopnea Index
0 to \>30/hour (high value represents worse outcome)
Time frame: Baseline, 3, and 12 months
Population: Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tongue Suspension | Apnea Hypopnea Index | Baseline | 24.2 events/hour | Standard Deviation 10.3 |
| Tongue Suspension | Apnea Hypopnea Index | 3 months | 15.9 events/hour | Standard Deviation 7.8 |
| Tongue Suspension | Apnea Hypopnea Index | 12 months | 34.6 events/hour | Standard Deviation 6.6 |
Secondary
Epworth Sleeping Scale (ESS)
0 to 24 (high value represents worse outcome)
Time frame: Baseline, 1, 3, 12 months
Population: Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tongue Suspension | Epworth Sleeping Scale (ESS) | Baseline | 12.4 units on a scale | Standard Deviation 4 |
| Tongue Suspension | Epworth Sleeping Scale (ESS) | 1 month | 7.7 units on a scale | Standard Deviation 2.2 |
| Tongue Suspension | Epworth Sleeping Scale (ESS) | 3 months | 7 units on a scale | Standard Deviation 2.4 |
| Tongue Suspension | Epworth Sleeping Scale (ESS) | 12 months | 6.5 units on a scale | Standard Deviation 2.1 |
Secondary
Functional Outcomes and Sleep Questionnaire (FOSQ)
Questionnaire: 0 to 120 (high value represents better outcome)
Time frame: Baseline, 1, 3, 12 months
Population: Four (4) of 5 total subjects had data at baseline and follow-up data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tongue Suspension | Functional Outcomes and Sleep Questionnaire (FOSQ) | Baseline | 17.2 units on a scale | Standard Deviation 1.6 |
| Tongue Suspension | Functional Outcomes and Sleep Questionnaire (FOSQ) | 1 month | 18.2 units on a scale | Standard Deviation 1.9 |
| Tongue Suspension | Functional Outcomes and Sleep Questionnaire (FOSQ) | 3 months | 18.1 units on a scale | Standard Deviation 2.1 |
| Tongue Suspension | Functional Outcomes and Sleep Questionnaire (FOSQ) | 12 months | 17.2 units on a scale | Standard Deviation 2.4 |
Secondary
Snoring Scale (VAS)
0 to 10 (high value represents worse outcome)
Time frame: Baseline, 1 week; 1 month, 3 months, 12 months
Population: Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tongue Suspension | Snoring Scale (VAS) | 1 week | 2.6 units on a scale | Standard Deviation 2.3 |
| Tongue Suspension | Snoring Scale (VAS) | 1 month | 1.8 units on a scale | Standard Deviation 1 |
| Tongue Suspension | Snoring Scale (VAS) | 12 months | 1.7 units on a scale | Standard Deviation 2.4 |
| Tongue Suspension | Snoring Scale (VAS) | Baseline | 5.5 units on a scale | Standard Deviation 3.4 |
| Tongue Suspension | Snoring Scale (VAS) | 3 months | 1.8 units on a scale | Standard Deviation 1.6 |