CAP Pilot Study for Obstructive Sleep Apnea (OSA)

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: CAP

• Registration Number: NCT02309749
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-02
• Primary Completion: 2014-09
• Status Verified: 2014-12
• Study Completion: 2014-12
• Study First Submitted QC: 2014-12-03
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• Contraindicated for CPAP therapy
• Medically unstable condition/diagnosis that is not yet under control
• Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
• Periodic Leg MOvement Arousal Index greater than 15/hr
• Home titration of longer than 5 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Naive cohort	CAP	-

Primary Outcome Measures

Name	Time	Method
Accuracy of delivery of SMS messages to participant	30 days	Cross check recieved messages logged in a diary by the participant to those sent by CAP

Secondary Outcome Measures

Name	Time	Method
Participant CPAP Adherence	30 nights	Assess the adherence of participants to CPAP therapy while enrolled in CAP

Trial Locations

Locations (2)

Clayton Sleep Institute; 🇺🇸 St Louis, Missouri, United States

Sleep Therapy Research Center; 🇺🇸 San Antonio, Texas, United States