NCT01901055|TerminatedResultsDMC
Study Stopped
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.
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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.
DOTT
The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
Sponsor study identifier
interventional
98
1 country
4
Study Start
February 13, 2014
Actual (reported)Primary Completion
May 8, 2019
Actual (reported)Study Completion
May 8, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 8, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2013
Actual (reported)July 17, 2013
Actual (reported)February 13, 2014
Actual (reported)May 8, 2019
Actual (reported)May 8, 2019
Actual (reported)August 13, 2021
Actual (reported)HbA1C Level
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
Fructosamine Level
baseline, 6 weeks, 12 weeks
Diabetes Diet Adherence
baseline, 6 weeks, 12 weeks
Diabetes Knowledge
baseline,12 weeks only
Self-Monitoring of Blood Glucose (SMBG)
baseline, 6 weeks, 12 weeks
Steps Walked
baseline, 6 weeks, 12 weeks
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
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).
John D. Dingell VAMC
Detroit, Michigan, 48201, United States
Pittsburgh Veterans Administration Medical Center
Pittsburgh, Pennsylvania, 15240, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9.
Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2.
Recruitment was negatively affected by a large number of persons screened who were ineligible because of either their, or a family member, having prior CPAP treatment. Recruitment was also affected by persons who did not want the possibility of being randomized to be on a sham-CPAP device for 12 weeks.
Eileen R. Chasens, PhD
University of Pittsburgh
98 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2013
First Posted
July 17, 2013
Study Start
February 13, 2014
Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study
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).
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 8, 2019
Actual (reported)Study Completion
May 8, 2019
Actual (reported)Last Updated
August 16, 2021
Results First Posted
August 13, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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