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OpenTrials
Completed

NCT Number: NCT02309749

CAP Pilot Study for Obstructive Sleep Apnea (OSA)

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.

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Key information

Conditions

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

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clayton Sleep Institute, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAP

Other

Primary outcomes

  1. Accuracy of delivery of SMS messages to participant

    Time frame: 30 days

    Cross check recieved messages logged in a diary by the participant to those sent by CAP

Secondary outcomes

  1. Participant CPAP Adherence

    Time frame: 30 nights

    Assess the adherence of participants to CPAP therapy while enrolled in CAP

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2014
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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