CAP Pilot Study for Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309749
• Other study ID #: FPH-AD13-01
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: December 4, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• CAP

Locations

Country	Name	City	State
United States	Sleep Therapy Research Center	San Antonio	Texas
United States	Clayton Sleep Institute	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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