Phase 1
Completed N=118
Tailored Intervention to Promote Positive Airway Pressure Adherence
Sleep Apnea, Obstructive · Patient Compliance
Source: ClinicalTrials.gov NCT01454830 ↗
Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Nightly CPAP Use — 6.4; 5.8 hours/night — p=0.20
Summary
The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nightly CPAP Use |
4.8; 4.7 | 0.89 |
| SECONDARY Proportion of Sleep Time on CPAP |
64.58; 65.73 | 0.78 |
| SECONDARY Proportion of Participants Who Complete Protocol After Allocation |
88.5; 86 | — |
| SECONDARY Proportion of Participants Who Withdrawal |
6.56; 7.02 | — |
| SECONDARY Acceptability of Study Intervention and Comparative Group |
100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- males and females >/= 18 years of age
- newly diagnosed with apnea/hypopnea index >/= 10 events/hr
- CPAP naive
- able to read and speak English
Exclusion Criteria
- previous diagnosis and/or treatment of OSA
- major new psychiatric diagnosis within 6 months of study enrollment
- require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
- diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
Data sourced from ClinicalTrials.gov (NCT01454830). 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. Informational only — not medical advice.