CAP Pilot Study for Obstructive Sleep Apnea (OSA)

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: CAP

Study type: Observational

Funder types: Industry

Identifiers

NCT02309749

FPH-AD13-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

50 participants in 1 patient group

Naive cohort

Treatment:

Other: CAP