Adherence Risk Indicator Validation Study

NCT02230085 | Completed Results

• 1 other identifier: CIA-121
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• CPAP Therapy Adherence

  Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.

  90 days

Study Arms (1)

CPAP therapy

Other: Administration of the questionnaire and monitoring of CPAP adherence

Interventions

Administration of the questionnaire and monitoring of CPAP adherence OTHER

CPAP therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient recieving CPAP for OSA.

You may qualify if:

• ≥ 18years of age
• Diagnosed with OSA (AHI \>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
• Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years

You may not qualify if:

• 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)
• PLMA (Periodic Limb Movement Activity) Index greater than 15/hr
• Home titration of longer than 5 days

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

EverythingCPAP

Boise, Idaho, 83704, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Fisher & Paykel Healthcare

cpaptrial@fphcare.co.nz

+6495740123

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: September 3, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 3, 2017
• Results First Posted: December 2, 2016

Record last verified: 2017-01

Locations

US (1)