This trial is active, not recruiting.

Conditions sleep apnea, obstructive, patient compliance
Treatments tailored, usual care
Phase phase 1
Sponsor Milton S. Hershey Medical Center
Collaborator National Institute of Nursing Research (NINR)
Start date November 2011
End date February 2014
Trial size 72 participants
Trial identifier NCT01454830, 37007, 4R00NR011173


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions
tailored Individualized
Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
(Active Comparator)
The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment
usual care standard of care
Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care

Primary Outcomes

Nightly CPAP use
time frame: 1 week
Nightly CPAP use
time frame: 1 month
Nightly CPAP use
time frame: 3 months

Secondary Outcomes

Proportion of sleep time on CPAP
time frame: 1 week
Proportion of patients enrolled after positive screening
time frame: 24 months
Proportion of participants complete protocol
time frame: 24 months
Proportion of participants who withdrawal
time frame: 24 months
Study personnel training costs
time frame: 24 months
Acceptability of study intervention and comparative group
time frame: 3 months
Proportion of sleep time using CPAP
time frame: 1 month
Proportion of sleep time using CPAP
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
Principal investigator Amy M Sawyer, PhD
Description Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.