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

Adherence Risk Indicator Validation Study (ARI)

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ClinicalTrials.gov Identifier: NCT02230085
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : December 2, 2016
Last Update Posted : March 3, 2017
Sponsor:
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

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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.



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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02230085


Locations
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United States, Idaho
EverythingCPAP
Boise, Idaho, United States, 83704
Sponsors and Collaborators
Fisher and Paykel Healthcare

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov 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:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases