Obstructive Sleep Apnea Clinical Trial
Verified date | December 2014 |
Source | Fisher and Paykel Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 75 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Sleep Therapy Research Center | San Antonio | Texas |
United States | Clayton Sleep Institute | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Fisher and Paykel Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of delivery of SMS messages to participant | Cross check recieved messages logged in a diary by the participant to those sent by CAP | 30 days | No |
Secondary | Participant CPAP Adherence | Assess the adherence of participants to CPAP therapy while enrolled in CAP | 30 nights | No |
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