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Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial

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ClinicalTrials.gov Identifier: NCT02245659
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sushmita Pamidi, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE April 25, 2014
First Posted Date  ICMJE September 19, 2014
Last Update Posted Date February 17, 2021
Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
Average nightly hours of CPAP use [ Time Frame: Up to 8 weeks ]
Calculated over the course of pregnancy, with objective measurement from CPAP device download. CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
  • Recruitment and retention rates in trial [ Time Frame: At completion of study (prior to delivery of baby) ]
  • Maternal glucose levels [ Time Frame: Throughout pregnancy until delivery ]
    Continuous glucose monitoring and capillary blood glucose checks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Official Title  ICMJE The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Brief Summary Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in pregnant patients with sleep-disordered breathing and gestational diabetes
Detailed Description

Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.

General Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.

Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy
  • Sleep-disordered Breathing
  • Gestational Diabetes
Intervention  ICMJE
  • Device: CPAP
    Continuous Positive Airway Pressure
  • Other: Nasal dilator strip
    Nasal dilator strip to be worn nightly
    Other Name: Breathe-Right Strip
Study Arms  ICMJE
  • Experimental: CPAP
    Intervention: Device: CPAP
  • Nasal dilator strip
    Control
    Intervention: Other: Nasal dilator strip
Publications * Pamidi S, Meltzer SJ, Garfield N, Lavigne L, Olha A, Khalyfa A, Benedetti A, Tremblay G, Gagnon R, Rey E, Dasgupta K, Kimoff RJ. A Pilot Randomized-Controlled Trial on the Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: Study Design and Methods. Front Endocrinol (Lausanne). 2018 Nov 16;9:659. doi: 10.3389/fendo.2018.00659. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2021)
46
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2014)
60
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre
  • >20 weeks and <34 weeks gestational age at time of recruitment
  • Gestational diabetes
  • Sleep-disordered breathing (SDB)

Exclusion Criteria:

  • Pre-gestational type 1 or type 2 diabetes
  • Multiple pregnancy
  • Conception by IVF
  • Prior treatment for SDB
  • severe medical illness
  • Severe SDB (AHI >30) and Epworth Sleepiness Scale >15 or oxygen desaturation index >30 or sustained hypoxia < 80%
  • Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)
  • Cigarette smoking, alcohol consumption or illicit drug use
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02245659
Other Study ID Numbers  ICMJE RN-326488
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sushmita Pamidi, McGill University Health Centre/Research Institute of the McGill University Health Centre
Original Responsible Party Same as current
Current Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP