N/A
N=28
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Treatment for Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT04029311 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Apnea-Hypopnea Index — 4.1; 3.6 episodes/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nuance Pro (Device); autoPAP (Device); TAP PAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joseph Adame
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-Hypopnea Index |
4.1; 3.6 | — |
| PRIMARY PAP Pressure |
9.6; 8.6 | — |
| PRIMARY Leaks |
15.1; 16.7 | — |
| PRIMARY Hours of Use |
6.0; 5.9 | — |
| PRIMARY Epworth Sleepiness Scale (ESS) |
5.5; 5.8 | — |
| PRIMARY Functional Outcomes Sleep Questionnaire (FOSQ) |
36.3; 36.2 | — |
| PRIMARY Intolerance Questionnaire |
2.7; 3.4 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04029311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.