Treatment for Obstructive Sleep Apnea Clinical Trial
Official title:
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
| NCT number | NCT04029311 |
| Other study ID # | 20170991 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 8, 2017 |
| Est. completion date | May 7, 2019 |
| Verified date | March 2021 |
| Source | Adame, J. Michael, D.D.S. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | May 7, 2019 |
| Est. primary completion date | February 6, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | J. Michael Adame, DDS, PA | Edinburg | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Joseph Adame |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Apnea-Hypopnea Index | Episodes per hour that the patient experiences apneas and/or hypopneas | 2 months | |
| Primary | PAP Pressure | The pressure required to treat the patient successfully | 2 months | |
| Primary | Leaks | The Liters/Minute of leaking of the PAP machine | 2 months | |
| Primary | Hours of Use | The average hours of use per night of each of the combination therapies | 2 months | |
| 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. | 2 months | |
| 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. | 2 months | |
| 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. | 2 months |