Portable Monitoring for Diagnosis and Management of Sleep Apnea

NCT00642486 | Completed DMC

• 1 other identifier: ASMF 38-PM-07
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

Conditions

Sleep Apnea, Obstructive

Keywords

treatment; positive airway pressure; compliance; cost effectiveness; clinical trial

Outcome Measures

Primary Outcomes (1)

• Acceptance of CPAP treatment

  from diagnosis to effective treatment

Secondary Outcomes (1)

• Compliance with CPAP therapy

  1 and 3 month post acceptance

Study Arms (2)

1

ACTIVE COMPARATOR

laboratory-based testing

Other: Standard polysomnography (PSG)

2

ACTIVE COMPARATOR

home-based testing

Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)

Interventions

Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) OTHER

portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.

2

Standard polysomnography (PSG) OTHER

laboratory-based testing

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intermediate to high probability of having OSA based on an adjusted neck circumference \> 43 cm (17 inches)
• Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index \>= 15 on diagnostic testing to continue in study

You may not qualify if:

• Severe chronic insomnia, other condition with \< 4 hrs of sleep per night
• Unstable medical conditions
• Major psychiatric diagnosis
• Unable to undergo home testing
• Concerns about unsafe driving
• Severe COPD or restrictive lung disease
• Chronic narcotic use
• Alcohol abuse
• History of cataplexy
• Moderate to severe restless legs syndrome symptoms
• Pre-existing diagnosis of sleep apnea
• Prior experience with positive airway pressure treatment of sleep apnea
• Anticipated upper airway surgery or gastric bypass surgery in 4 months
• Decisional impairment for consenting
• Hypoventilation syndrome, identified in the medical record

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator
• The Cleveland Clinic: collaborator
• MetroHealth Medical Center: collaborator
• University of Washington: collaborator
• University of Minnesota: collaborator
• Northwestern University: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (6)

• Pascoe M, Bena J, Andrews ND, Auckley D, Benca R, Billings ME, Kapur VK, Iber C, Zee PC, Redline S, Rosen CL, Foldvary-Schaefer N. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study. J Clin Sleep Med. 2022 Apr 1;18(4):1027-1034. doi: 10.5664/jcsm.9792.

  PMID: 34870587 DERIVED

• Kim RD, Kapur VK, Redline-Bruch J, Rueschman M, Auckley DH, Benca RM, Foldvary-Schafer NR, Iber C, Zee PC, Rosen CL, Redline S, Ramsey SD. An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea. Sleep. 2015 Jul 1;38(7):1027-37. doi: 10.5665/sleep.4804.

  PMID: 26118558 DERIVED

• Billings ME, Rosen CL, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Zee PC, Redline S, Kapur VK. Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study. Sleep. 2014 Dec 1;37(12):2017-24. doi: 10.5665/sleep.4262.

  PMID: 25325491 DERIVED

• Billings ME, Rosen CL, Wang R, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Zee P, Redline S, Kapur VK. Is the relationship between race and continuous positive airway pressure adherence mediated by sleep duration? Sleep. 2013 Feb 1;36(2):221-7. doi: 10.5665/sleep.2376.

  PMID: 23372269 DERIVED

• Rosen CL, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Kapur V, Rueschman M, Zee P, Redline S. A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. Sleep. 2012 Jun 1;35(6):757-67. doi: 10.5665/sleep.1870.

  PMID: 22654195 DERIVED

• Billings ME, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Redline S, Rosen CL, Zee P, Kapur VK. Race and residential socioeconomics as predictors of CPAP adherence. Sleep. 2011 Dec 1;34(12):1653-8. doi: 10.5665/sleep.1428.

  PMID: 22131602 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carol L Rosen, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 25, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 5, 2025

Record last verified: 2008-03

Locations

US (1)