Working… Menu
Trial record 17 of 2645 for:    ( Map: Idaho, United States )

Adherence Risk Indicator Validation Study (ARI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02230085
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : December 2, 2016
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Other: Administration of the questionnaire and monitoring of CPAP adherence

Layout table for study information
Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
CPAP therapy Other: Administration of the questionnaire and monitoring of CPAP adherence

Primary Outcome Measures :
  1. CPAP Therapy Adherence [ Time Frame: 90 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient recieving CPAP for OSA.

Inclusion Criteria:

  • ≥ 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02230085

Layout table for location information
United States, Idaho
Boise, Idaho, United States, 83704
Sponsors and Collaborators
Fisher and Paykel Healthcare

Layout table for additonal information
Responsible Party: Fisher and Paykel Healthcare Identifier: NCT02230085     History of Changes
Other Study ID Numbers: CIA-121
First Posted: September 3, 2014    Key Record Dates
Results First Posted: December 2, 2016
Last Update Posted: March 3, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases