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Completed

NCT Number: NCT02553694

Sleep Apnea Video Education for CPAP (SAVE-CPAP)

The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged > 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
  • Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.

Exclusion criteria

Subjects will be excluded for any of the following characteristics: -Non-English speaking

  • Illiterate
  • Sleep study is negative for sleep apnea (apnea-hypopnea index < 5 events/hr)
  • Subject does not undergo CPAP titration during the in-laboratory polysomnogram
  • Subject does not have a working telephone number
  • Poor eyesight or hearing
  • Dementia

Treatment and study plan

Enhanced education

Other

Investigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram.

Usual education

Other

Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets

Usual follow up

Other

MD will follow up by phone after the in-laboratory split night polysomnogram

Enhanced follow up

Other

Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram

Primary outcomes

  1. CPAP Therapy Adherence

    Time frame: 30 days post in-lab split night polysomnogram

    Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.

Secondary outcomes

  1. Subject compliance with sleep clinic appointment

    Time frame: within 3 months after the in-laboratory split night polysomnogram

    Subjects will be randomized to receive a reminder call for follow up clinic appointment either from MD or staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.

  2. Patient Knowledge About Sleep Apnea and CPAP Therapy

    Time frame: 1 day post in-laboratory split night polysomnogram

    Subjects will be administered 2 questionnaires which measure knowledge about their condition, both before and after the in-laboratory split night polysomnogram (sleep study). The scores of the two questionnaires will be combined for both test administrations. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to sleep study and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.

  3. Patient Satisfaction With the in-laboratory split night polysomnogram

    Time frame: 1 day post in-laboratory split night polysomnogram

    Subjects will be administered 2 questionnaires which measure their mood and well-being, both before and after the in-laboratory split night polysomnogram. The questionnaires will be scored and the scores for each subject will be combined at both testing administrations. On the night of the in-laboratory polysomnogram subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to the initiation of the polysomnogram and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.

  4. CPAP Therapy Adherence

    Time frame: 1 month post sleep clinic visit or the date of the missed sleep clinic visit

    Subjects will be randomized to receive a reminder call for follow up sleep clinic appointment either from MD or non-MD sleep center staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes

Acronym: SAVE-CPAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Mar 3, 2017

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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