CAP Pilot Study for Obstructive Sleep Apnea (OSA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Naive cohort

CAP

Intervention Type OTHER

Interventions

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CAP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 21 to 75 years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
* Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
* Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
* Access to a cellphone

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clayton Sleep Institute

St Louis, Missouri, United States

Site Status

Sleep Therapy Research Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FPH-AD13-01

Identifier Type: -

Identifier Source: org_study_id