Sleep Apnea, Obstructive Clinical Trial
— SCIP-PAOfficial title:
Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
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.
Status | Active, not recruiting |
Enrollment | 72 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | National Institute of Nursing Research (NINR), Sigma Theta Tau International |
United States,
Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns. 2011 Oct;85(1):85-91. doi: 10.1016/j.pec.2010.10.014. Epub 2010 Nov 10. — View Citation
Sawyer AM, Deatrick JA, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qual Health Res. 2010 Jul;20(7):873-92. doi: 10.1177/1049732310365502. Epub 2010 Mar 30. — View Citation
Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8. Review. — View Citation
Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, Pack AI. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep. 2003 Sep;26(6):727-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nightly CPAP use | Mean CPAP use, hrs/night | 1 week | No |
Primary | Nightly CPAP use | Mean CPAP use, hrs/night | 1 month | No |
Primary | Nightly CPAP use | Mean CPAP use, hrs/night | 3 months | No |
Secondary | Proportion of sleep time on CPAP | % of Total Sleep Time (TST) using CPAP | 1 week | No |
Secondary | Proportion of patients enrolled after positive screening | Feasibility assessment | 24 months | No |
Secondary | Proportion of participants complete protocol | Feasibility assessment | 24 months | No |
Secondary | Proportion of participants who withdrawal | Feasibility assessment | 24 months | No |
Secondary | Study personnel training costs | Feasibility assessment aimed at projecting budget requirements for subsequent larger trial | 24 months | No |
Secondary | Acceptability of study intervention and comparative group | Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study debriefing (3 months) | 3 months | No |
Secondary | Proportion of sleep time using CPAP | % of total sleep time (TST) using CPAP | 1 month | No |
Secondary | Proportion of sleep time using CPAP | % of total sleep time (TST) using CPAP | 3 months | No |
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