NCT02553694

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

August 5, 2014

Last Update Submit

March 2, 2017

Conditions

Obstructive Sleep Apnea

Keywords

OSA, Apnea

Outcome Measures

Primary Outcomes (1)

  • CPAP Therapy Adherence

    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.

    30 days post in-lab split night polysomnogram

Secondary Outcomes (4)

  • Subject compliance with sleep clinic appointment

    within 3 months after the in-laboratory split night polysomnogram

  • Patient Knowledge About Sleep Apnea and CPAP Therapy

    1 day post in-laboratory split night polysomnogram

  • Patient Satisfaction With the in-laboratory split night polysomnogram

    1 day post in-laboratory split night polysomnogram

  • CPAP Therapy Adherence

    1 month post sleep clinic visit or the date of the missed sleep clinic visit

Study Arms (4)

Enhanced education and Enhanced follow up

EXPERIMENTAL

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

Other: Enhanced educationOther: Usual follow up

Usual education and Usual follow up

ACTIVE COMPARATOR

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

Other: Usual educationOther: Enhanced follow up

Enhanced education and Usual follow up

EXPERIMENTAL

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

Other: Enhanced educationOther: Enhanced follow up

Usual education with Enhanced follow up

EXPERIMENTAL

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

Other: Usual educationOther: Usual follow up

Interventions

Enhanced educationOTHER

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 education and Enhanced follow upEnhanced education and Usual follow up
Usual educationOTHER

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

Usual education and Usual follow upUsual education with Enhanced follow up
Usual follow upOTHER

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

Enhanced education and Enhanced follow upUsual education with Enhanced follow up
Enhanced follow upOTHER

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

Enhanced education and Usual follow upUsual education and Usual follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (4)

  • 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.

    PMID: 21253882BACKGROUND

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

    PMID: 22005190BACKGROUND

  • 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.

    PMID: 23493772BACKGROUND

  • 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.

    PMID: 28667231DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveApnea

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Babak Mokhlesi, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

September 17, 2015

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)