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History of Changes for Study: NCT02245659
Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Latest version (submitted February 15, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 17, 2014 None (earliest Version on record)
2 April 3, 2015 Recruitment Status, Study Status and Contacts/Locations
3 March 15, 2016 Arms and Interventions and Study Status
4 March 24, 2017 Study Status and IPDSharing
5 August 14, 2018 Study Status
6 February 15, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Identification
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Study NCT02245659
Submitted Date:  September 17, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: RN-326488
Brief Title: Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Official Title: The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2014
Overall Status: Not yet recruiting
Study Start: October 2014
Primary Completion: October 2016 [Anticipated]
Study Completion:
First Submitted: April 25, 2014
First Submitted that
Met QC Criteria:
September 17, 2014
First Posted: September 19, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 17, 2014
Last Update Posted: September 19, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party: Principal Investigator
Investigator: Sushmita Pamidi
Official Title: Assistant Professor of Medicine
Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Pregnancy
Sleep-disordered Breathing
Gestational Diabetes
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CPAP Device: CPAP
Continuous Positive Airway Pressure
Placebo Comparator: Nasal dilator strip
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)
Secondary Outcome Measures:
1. Recruitment and retention rates in trial
[ Time Frame: At completion of study (prior to delivery of baby) ]

2. Maternal glucose levels
[ Time Frame: Throughout pregnancy until delivery ]

Continuous glucose monitoring and capillary blood glucose checks
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Sushmita Pamidi, MD
Telephone: 514-934-1934 Ext. 36479
Email: sushmita.pamidi@mcgill.ca
Locations: Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A2Y3
Contact:Principal Investigator: Sushmita Pamidi, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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