N/A
N=60
COMMunication and Education for the New CPAP Experience
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01377584 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Daytime Sleepiness — 9.0; 3.8; 6.8; 6.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Couple-oriented intervention (Behavioral); Patient-oriented intervention (Behavioral); Continuous positive airway pressure (CPAP) (Device); No intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daytime Sleepiness |
9.0; 3.8; 6.8; 6.5; 10.8; 7.3 | — |
| PRIMARY Sleep-related Functional Outcomes |
16.6; 16.7; 17.2; 16.9; 15.6; 17.3 | — |
| PRIMARY Sleep Quality |
8.4; 7.0; 7.8; 7.2; 8.3; 9.9 | — |
| SECONDARY Continuous Positive Airway Pressure (CPAP) Adherence |
5.6; 4.5; 5.8; 6.1; 5.0; 5.1 | — |
Summary
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
Eligibility Criteria
Inclusion Criteria
Patient:
- Age is 21 years of age and older
- Have spouse or partner
- Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
- Choice of continuous positive airway pressure (CPAP) as preferred treatment
Partner:
- Age is 18 years of age and older
- Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment
Exclusion Criteria
Patient:
- AHI < 5 on the diagnostic PSG
- Have a spouse or partner with OSA diagnosis and on OSA treatment
- Past treatment for OSA
- Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
- Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
- History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner:
- Have been diagnosed with OSA and using CPAP
Data sourced from ClinicalTrials.gov (NCT01377584). 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.