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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 : Recruiting
First Posted : September 19, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Sushmita Pamidi, McGill University Health Center

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

Condition or disease Intervention/treatment Phase
Pregnancy Sleep-disordered Breathing Gestational Diabetes Device: CPAP Other: Nasal dilator strip Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPAP Device: CPAP
Continuous Positive Airway Pressure

Nasal dilator strip
Control
Other: Nasal dilator strip
Nasal dilator strip to be worn nightly
Other Name: Breathe-Right Strip




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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

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): NCT02245659


Contacts
Contact: Sushmita Pamidi, MD 514-934-1934 ext 36479 sushmita.pamidi@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A2Y3
Principal Investigator: Sushmita Pamidi, MD         
Sponsors and Collaborators
McGill University Health Center

Responsible Party: Sushmita Pamidi, Assistant Professor of Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02245659     History of Changes
Other Study ID Numbers: RN-326488
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications