Treatment for Obstructive Sleep Apnea
Conditions
Brief summary
To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1\. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of: 1. Apnea Hypopnea Index (AHI) reduction 2. Amount of side effects 3. Amount of Leaks 4. Hours of use (compliance) 5. CPAP pressure 2\. There is a difference between connected and disconnected for the following symptoms: 1. Epworth sleepiness Scale (ESS) 2. Functional Outcomes of Sleep Questionnaire (FOSQ) 3. Side effects Study Design - randomized prospective parallel
Interventions
DEVICENuance Pro
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
DEVICEautoPAP
autoPAP
DEVICETAP PAP
TAP PAP
Sponsors
Joseph Adame
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Baseline diagnosis AHI \> or = 5 plus ESS . or = 10. * PAP Intolerance * Partial Response to oral appliance therapy: AHI \> 5 * Age: \> 18
Exclusion criteria
History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants. * Diagnosis of Central Sleep Apnea * Pregnancy * Edentulous * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index | 2 months | Episodes per hour that the patient experiences apneas and/or hypopneas |
| PAP Pressure | 2 months | The pressure required to treat the patient successfully |
| Leaks | 2 months | The Liters/Minute of leaking of the PAP machine |
| Hours of Use | 2 months | The average hours of use per night of each of the combination therapies |
| Epworth Sleepiness Scale (ESS) | 2 months | The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. |
| Functional Outcomes Sleep Questionnaire (FOSQ) | 2 months | FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life. |
| Intolerance Questionnaire | 2 months | This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combination Therapy With Preferred Mask Preferred Mask refers to a type of existing medical mask used for PAP therapy.
Nuance Pro: Study compares Nuance Pro plus autoPAP vs TAP PAP plus autoPAP
autoPAP: autoPAP | 15 |
| Combination Therapy With Custom Mask Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.
autoPAP: autoPAP
TAP PAP: TAP PAP | 13 |
| Total | 28 |
Baseline characteristics
| Characteristic | Combination Therapy With Preferred Mask | Combination Therapy With Custom Mask | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Continuous | 57.9 years STANDARD_DEVIATION 12.7 | 54.5 years STANDARD_DEVIATION 8.6 | 56.3 years STANDARD_DEVIATION 10.9 |
| BMI | 34.4 kg/m^2 STANDARD_DEVIATION 8.4 | 32.9 kg/m^2 STANDARD_DEVIATION 7.5 | 33.8 kg/m^2 STANDARD_DEVIATION 7.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 15 participants | 13 participants | 28 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
Primary
Apnea-Hypopnea Index
Episodes per hour that the patient experiences apneas and/or hypopneas
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Apnea-Hypopnea Index | 4.1 episodes/hour | Standard Deviation 3.6 |
| Combination Therapy With Custom Mask | Apnea-Hypopnea Index | 3.6 episodes/hour | Standard Deviation 2.7 |
Primary
Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Epworth Sleepiness Scale (ESS) | 5.5 score on a scale | Standard Deviation 4 |
| Combination Therapy With Custom Mask | Epworth Sleepiness Scale (ESS) | 5.8 score on a scale | Standard Deviation 2.7 |
Primary
Functional Outcomes Sleep Questionnaire (FOSQ)
FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Functional Outcomes Sleep Questionnaire (FOSQ) | 36.3 score on a scale | Standard Deviation 3.8 |
| Combination Therapy With Custom Mask | Functional Outcomes Sleep Questionnaire (FOSQ) | 36.2 score on a scale | Standard Deviation 2.8 |
Primary
Hours of Use
The average hours of use per night of each of the combination therapies
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Hours of Use | 6.0 hours per night | Standard Deviation 1.9 |
| Combination Therapy With Custom Mask | Hours of Use | 5.9 hours per night | Standard Deviation 2.4 |
Primary
Intolerance Questionnaire
This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Intolerance Questionnaire | 2.7 score on a scale | Standard Deviation 2.4 |
| Combination Therapy With Custom Mask | Intolerance Questionnaire | 3.4 score on a scale | Standard Deviation 2.7 |
Primary
Leaks
The Liters/Minute of leaking of the PAP machine
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | Leaks | 15.1 L/min | Standard Deviation 8 |
| Combination Therapy With Custom Mask | Leaks | 16.7 L/min | Standard Deviation 14.1 |
Primary
PAP Pressure
The pressure required to treat the patient successfully
Time frame: 2 months
Population: Missing data from 1 participant in Combination Therapy with Preferred Mask group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy With Preferred Mask | PAP Pressure | 9.6 cmH2O | Standard Deviation 1.8 |
| Combination Therapy With Custom Mask | PAP Pressure | 8.6 cmH2O | Standard Deviation 1.9 |