Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945776
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Information provided by:
CAMC Health System

Brief Summary:
The purpose of this study is to compare the effects of three interventions on CPAP adherence.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Behavioral: Weekly phone calls Behavioral: Frequently asked questions Behavioral: Usual care Phase 2

Detailed Description:
To determine whether there is a need for a more intensive one on one interaction with the patient in order to improve CPAP usage. And also to try to identify in general which population of patients may require a more intensive intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial
Study Start Date : April 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Weekly phone calls
Will be called weekly to answer questions regarding usage.
Behavioral: Weekly phone calls
Calling weekly to answer questions regarding CPAP usage.
Active Comparator: Frequently asked questions
Providing written general answers to commonly asked questions.
Behavioral: Frequently asked questions
Answers to frequently asked questions in pre-printed form.
Active Comparator: Usual care Behavioral: Usual care
Answers will be provided by the renter of the equipment, and the sleep center if asked in addition to explanations by the sleep specialist.

Primary Outcome Measures :
  1. To determine which intervention will improve CPAP compliance in sleep apnea [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. To try to identify which individual characteristics within a group may require a specific intervention [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All new patients undergoing of the Sleep Center suspected of having sleep apnea and undergoing sleep studies

Exclusion Criteria:

  • Refusal to participate, or not suspected of having sleep apnea prior to the study

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 identifier (NCT number): NCT00945776

United States, West Virginia
CAMC Sleep Center
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
CAMC Health System
Principal Investigator: George L Zaldivar, M.D. CAMC Health System

Responsible Party: George L. Zaldivar, M.D., CAMC Identifier: NCT00945776     History of Changes
Other Study ID Numbers: 08-04-2047
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by CAMC Health System:

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