COMMENCE Study: COMMunication and Education for the New CPAP Experience
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Apnea, Obstructive
- Sponsor
- University of Pittsburgh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Daytime Sleepiness
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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).
Detailed Description
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
Investigators
Faith Luyster
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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
- •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
- •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
Outcomes
Primary Outcomes
Daytime Sleepiness
Time Frame: baseline and 3 months after CPAP initiation
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness.
Sleep Quality
Time Frame: baseline and 3 months after CPAP initiation
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score \> 5 indicates a poor sleeper.
Sleep-related Functional Outcomes
Time Frame: baseline and 3 months after CPAP initiation
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.
Secondary Outcomes
- Continuous Positive Airway Pressure (CPAP) Adherence(one week, one month, and 3 months after CPAP initiation)