PMID- 30517889
OWN - NLM
STAT- MEDLINE
DCOM- 20200311
LR  - 20240322
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Print)
IS  - 1551-7144 (Linking)
VI  - 76
DP  - 2019 Jan
TI  - Diabetes sleep treatment trial: Premise, design, and methodology.
PG  - 104-111
LID - S1551-7144(18)30285-4 [pii]
LID - 10.1016/j.cct.2018.11.014 [doi]
AB  - The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, 
      randomized, sham-controlled trial. The study objective is to test whether 
      treatment of obstructive sleep apnea (OSA) with continuous positive airway 
      pressure (CPAP) treatment results in improved glycemic control and diabetes 
      self-management behavior compared to participants on a sham-CPAP 
      (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and 
      co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, 
      the study design, and the methodology used in this on-going trial. The target 
      enrollment is 210 randomly assigned participants recruited from two sites. The 
      primary outcome for glucose control is HbA1C; additional outcomes for diabetes 
      self-management include objectively measured steps walked and subjectively 
      measured diabetes-related distress, diabetes empowerment, and diabetes knowledge. 
      All participants receive individual diabetes education and counseling for 6 weeks 
      over two individual sessions and three telephone calls. Participants are 
      randomized to receive either sham or active CPAP for 12 weeks, after which, they 
      "guess" their group assignment; this will assist in determining the success of 
      blinding participants to treatment group assignment. Participants revealed to be 
      on active CPAP will be encouraged to continue CPAP for an additional 12 weeks; 
      participants who had been on sham devices will be encouraged to have a repeat 
      CPAP titration study and to crossover to active CPAP treatment for 24 weeks. An 
      intention-to-treat approach will be used for efficacy analyses. The trial is 
      registered with Clinicaltrials.gov (NCT01901055).
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Chasens, Eileen R
AU  - Chasens ER
AD  - University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, 
      United States. Electronic address: chasense@pitt.edu.
FAU - Atwood, Charles W
AU  - Atwood CW
AD  - Veterans Administration Pittsburgh Healthcare System, University Drive C, 
      Pittsburgh, PA, United States.
FAU - Burke, Lora E
AU  - Burke LE
AD  - University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, 
      United States.
FAU - Korytkowski, Mary
AU  - Korytkowski M
AD  - University of Pittsburgh School of Medicine, 3601 Fifth Ave, Room 550, 
      Pittsburgh, PA, United States.
FAU - Stansbury, Robert
AU  - Stansbury R
AD  - West Virginia University School of Medicine, 4th Floor HSCN Room, Morgantown, WV 
      4062, United States.
FAU - Strollo, Patrick J
AU  - Strollo PJ
AD  - University of Pittsburgh School of Medicine, NW 628 UPMC Montefiore, 3459 Fifth 
      Avenue, Pittsburgh, PA, United States.
FAU - Sereika, Susan M
AU  - Sereika SM
AD  - University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, 
      United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT01901055
GR  - R01 DK096028/DK/NIDDK NIH HHS/United States
GR  - UL1 TR000005/TR/NCATS NIH HHS/United States
GR  - UL1 TR001857/TR/NCATS NIH HHS/United States
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20181202
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Humans
MH  - Comorbidity
MH  - *Continuous Positive Airway Pressure
MH  - *Diabetes Mellitus, Type 2/epidemiology/metabolism
MH  - Double-Blind Method
MH  - Exercise
MH  - *Glycated Hemoglobin/metabolism
MH  - Health Knowledge, Attitudes, Practice
MH  - Patient Participation
MH  - Psychological Distress
MH  - *Sleep Apnea, Obstructive/epidemiology/therapy
MH  - Treatment Outcome
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC6311443
MID - NIHMS1000290
OTO - NOTNLM
OT  - Clinical trial
OT  - Glucose control
OT  - Sleep apnea
OT  - Type 2 diabetes
EDAT- 2018/12/06 06:00
MHDA- 2020/03/12 06:00
PMCR- 2020/01/01
CRDT- 2018/12/06 06:00
PHST- 2018/05/25 00:00 [received]
PHST- 2018/11/16 00:00 [revised]
PHST- 2018/11/30 00:00 [accepted]
PHST- 2018/12/06 06:00 [pubmed]
PHST- 2020/03/12 06:00 [medline]
PHST- 2018/12/06 06:00 [entrez]
PHST- 2020/01/01 00:00 [pmc-release]
AID - S1551-7144(18)30285-4 [pii]
AID - 10.1016/j.cct.2018.11.014 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 
      2018 Dec 2.