Tailored Intervention to Promote Positive Airway Pressure Adherence (SCIP-PA)

Penn State Health

Status and phase: Completed; Phase 1

Conditions: Sleep Apnea, Obstructive; Patient Compliance

Treatments: Behavioral: Tailored; Other: Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01454830

4R00NR011173 (U.S. NIH Grant/Contract)

37007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 2 patient groups

Tailored

Experimental group

Description:

Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions

Treatment:

Behavioral: Tailored

Usual care

Active Comparator group

Description:

The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment

Treatment:

Other: Usual care