Diabetes-Obstructive Sleep Apnea Treatment Trial (DOTT)

August 13, 2021 updated by: Eileen R. Chasens

The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control

Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied.

The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM.

Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • John D. Dingell VAMC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15240
        • Pittsburgh Veterans Administration Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suboptimal glucose control (A1C ≥ 6.5%)
  • Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour)
  • age 18 years and older

Exclusion Criteria:

  • Poor glucose control (A1C > 11)
  • Type 1 or gestational diabetes
  • Sleep duration < 4 hrs
  • Acute medical or surgical conditions or hospitalization ≤ 3 months
  • Oxygen or bi-level PAP required
  • Prior CPAP or persons in household with CPAP
  • Employed in safety sensitive job
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active CPAP treatment
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
Device: CPAP
CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
  • Continuous Positive Airway Pressure
Behavioral: Diabetes Education
Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
Placebo Comparator: Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Device: CPAP
CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
  • Continuous Positive Airway Pressure
Behavioral: Diabetes Education
Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
Device: Sham-CPAP
Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Other Names:
  • Sham Continuous Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C Level
Time Frame: baseline, 6 weeks, 12 weeks
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fructosamine Level
Time Frame: baseline, 6 weeks, 12 weeks
Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00.
baseline, 6 weeks, 12 weeks
Diabetes Diet Adherence
Time Frame: baseline, 6 weeks, 12 weeks
Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet
baseline, 6 weeks, 12 weeks
Diabetes Knowledge
Time Frame: baseline,12 weeks only
Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks)
baseline,12 weeks only
Self-Monitoring of Blood Glucose (SMBG)
Time Frame: baseline, 6 weeks, 12 weeks
SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG
baseline, 6 weeks, 12 weeks
Steps Walked
Time Frame: baseline, 6 weeks, 12 weeks
Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00.
baseline, 6 weeks, 12 weeks
Self-Monitoring of Foot Care
Time Frame: baseline, 6 weeks, 12 weeks
Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care
baseline, 6 weeks, 12 weeks
Diabetes-Related Distress
Time Frame: baseline, 6 weeks, 12 weeks
Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
baseline, 6 weeks, 12 weeks
Sleep Quality
Time Frame: baseline, 6 weeks, 12 weeks
Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality.
baseline, 6 weeks, 12 weeks
Mood
Time Frame: baseline, 6 weeks, 12 weeks
Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
baseline, 6 weeks, 12 weeks
Vigilance
Time Frame: Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session
Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance.
Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eileen R. Chasens

Investigators

  • Principal Investigator: Eileen R. Chasens, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2014

Primary Completion (Actual)

May 8, 2019

Study Completion (Actual)

May 8, 2019

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01DK096028-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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