Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea

NCT00880165 | Completed Results DMC

• 1 other identifier: IIR 04-021
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is comparing home and in-laboratory testing of veterans with suspected obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home testing will be equally effective in improving quality of life but have lower cost than in-lab testing. These findings will allow veterans to have greater access to diagnosis and treatment of their sleep apnea.

Conditions

Obstructive Sleep Apnea

Keywords

Polysomnogram; Continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Cost

  VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.

  Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.

Secondary Outcomes (2)

• Functional Outcome of Sleep Questionnaire

  3 months

• Continuous Positive Airway Pressure Adherence

  3 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

In-laboratory testing followed by continuous positive airway pressure treatment

Device: Continuous positive airway pressure apparatus

Arm 2

ACTIVE COMPARATOR

Home unattended testing followed by continuous positive airway pressure treatment

Device: Continuous positive airway pressure apparatus

Interventions

Continuous positive airway pressure apparatus DEVICE

Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.

Also known as: CPAP

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals willing to participate must meet the following eligibility criteria prior to enrollment:
• Patients referred for a sleep evaluation for suspected sleep apnea.
• Age 18 years or older
• Living within 90 miles of the Sleep Center.

You may not qualify if:

• Individuals will be excluded from the study for the following reasons:
• Unable or unwilling to provide informed written consent.
• Lack of telephone access or inability to return for follow-up testing.
• A history of prior sleep evaluations, OSA treatment, or sleep disorder in addition to OSA.
• A clinically unstable chronic medical condition as defined by a new diagnosis or change in medical management in the previous 3 months of cardiac disease, thyroid disease, diabetes, depression or psychosis, cirrhosis, or recently diagnosed cancer.
• Individuals already on long term oxygen therapy or requiring bilevel positive airway pressure.
• Individuals with rotating shift work or irregular work schedules over the last 6 months.
• Suspected or confirmed to be pregnant. A pregnancy test will be performed using the urine sample obtained at the initial visit.
• Inability to complete the Assessment Battery - e.g. less than a 5th grade reading level

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Leonard Davis Institute of Health Economics

Philadelphia, Pennsylvania, 19104-6128, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

• Sunwoo B, Kuna ST. Ambulatory management of patients with sleep apnea: is there a place for portable monitor testing? Clin Chest Med. 2010 Jun;31(2):299-308. doi: 10.1016/j.ccm.2010.02.003.

  PMID: 20488288 RESULT

• Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44. doi: 10.1164/rccm.201011-1770OC. Epub 2011 Jan 21.

  PMID: 21471093 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Samuel T. Kuna, MD
• Organization: Philadelphia VA Medical Center

Samuel.Kuna@va.gov

215-823-4400

Study Officials

• Samuel T. Kuna, MD

  VA Medical Center, Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: November 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (2)