Sleep Apnea Video Education for CPAP (SAVE-CPAP)

NCT ID: NCT02553694

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Enhanced education and Enhanced follow up

Subjects will watch a short video and will be contacted by an MD by phone

Group Type EXPERIMENTAL

Enhanced education

Intervention Type 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 follow up

Intervention Type OTHER

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

Usual education and Usual follow up

Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone

Group Type ACTIVE_COMPARATOR

Usual education

Intervention Type OTHER

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

Enhanced follow up

Intervention Type OTHER

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

Enhanced education and Usual follow up

Subjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone

Group Type EXPERIMENTAL

Enhanced education

Intervention Type 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.

Enhanced follow up

Intervention Type OTHER

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

Usual education with Enhanced follow up

Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone

Group Type EXPERIMENTAL

Usual education

Intervention Type OTHER

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

Usual follow up

Intervention Type OTHER

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

Interventions

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Enhanced education

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.

Intervention Type OTHER

Usual education

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

Intervention Type OTHER

Usual follow up

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

Intervention Type OTHER

Enhanced follow up

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Babak Mokhlesi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.

Reference Type BACKGROUND
PMID: 21253882 (View on PubMed)

Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Epub 2011 Oct 13.

Reference Type BACKGROUND
PMID: 22005190 (View on PubMed)

Balachandran JS, Yu X, Wroblewski K, Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med. 2013 Mar 15;9(3):199-205. doi: 10.5664/jcsm.2476.

Reference Type BACKGROUND
PMID: 23493772 (View on PubMed)

Guralnick AS, Balachandran JS, Szutenbach S, Adley K, Emami L, Mohammadi M, Farnan JM, Arora VM, Mokhlesi B. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial. Thorax. 2017 Dec;72(12):1132-1139. doi: 10.1136/thoraxjnl-2017-210106. Epub 2017 Jun 30.

Reference Type DERIVED
PMID: 28667231 (View on PubMed)

Other Identifiers

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IRB14-0198

Identifier Type: -

Identifier Source: org_study_id

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