CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 118 enrolled
Drug / intervention
Tailored +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01454830
NCT01454830Phase 1Completed

Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence

Milton S. Hershey Medical Center·interventional·Posted Oct 19, 2011·Updated Nov 23, 2016

In Brief

A Phase 1 clinical trial evaluating Tailored and Usual care for Sleep Apnea, Obstructive and Patient Compliance. Completed, enrolled 118 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.7 years ago

Interventions

Tailoredbehavioral

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

Usual careother

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