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Diabetes-Obstructive Sleep Apnea Treatment Trial (DOTT)

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.
 
ClinicalTrials.gov Identifier: NCT01901055
Recruitment Status : Terminated (The study did not reach 50% of the proposed sample size. Recruitment slow because persons not interested in being randomized to a sham-control CPAP device or not CPAP naïve.)
First Posted : July 17, 2013
Results First Posted : August 13, 2021
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Eileen R. Chasens, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obstructive Sleep Apnea Device: CPAP Device: Sham-CPAP Behavioral: Diabetes Education Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
Actual Study Start Date : February 13, 2014
Actual Primary Completion Date : May 8, 2019
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 Name: 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 Name: Continuous Positive Airway Pressure

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 Name: Sham 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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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

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

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): NCT01901055


Locations
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United States, Michigan
John D. Dingell VAMC
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Pittsburgh Veterans Administration Medical Center
Pittsburgh, Pennsylvania, United States, 15240
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Eileen R. Chasens
Investigators
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Principal Investigator: Eileen R. Chasens, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Eileen R. Chasens, University of Pittsburgh:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eileen R. Chasens, Professor of Nursing, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01901055    
Other Study ID Numbers: 5R01DK096028-02 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2013    Key Record Dates
Results First Posted: August 13, 2021
Last Update Posted: August 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eileen R. Chasens, University of Pittsburgh:
sleep apnea
diabetes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases