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Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea (VSATT)

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ClinicalTrials.gov Identifier: NCT00880165
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Leonard Davis Institute of Health Economics
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continuous positive airway pressure apparatus Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cost Effective Strategy to Evaluate Veterans With Sleep Apnea
Study Start Date : November 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Arm 1
In-laboratory testing followed by continuous positive airway pressure treatment
Device: Continuous positive airway pressure apparatus
Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.
Other Name: CPAP

Active Comparator: Arm 2
Home unattended testing followed by continuous positive airway pressure treatment
Device: Continuous positive airway pressure apparatus
Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.
Other Name: CPAP




Primary Outcome Measures :
  1. Cost [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Functional Outcome of Sleep Questionnaire [ Time Frame: 3 months ]
    Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment

  2. Continuous Positive Airway Pressure Adherence [ Time Frame: 3 months ]
    Mean daily hours of use of continuous positive airway pressure over the 3 month intervention



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880165


Locations
United States, Pennsylvania
Leonard Davis Institute of Health Economics
Philadelphia, Pennsylvania, United States, 19104-6128
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
US Department of Veterans Affairs
Leonard Davis Institute of Health Economics
Investigators
Principal Investigator: Samuel T. Kuna, MD VA Medical Center, Philadelphia

Publications of Results:
Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00880165     History of Changes
Other Study ID Numbers: IIR 04-021
First Posted: April 13, 2009    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Polysomnogram
Continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases