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

McGill University Health Centre/Research Institute of the McGill University Health Centre46 enrolled

Overview

Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in pregnant patients with sleep-disordered breathing and gestational diabetes

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pregnancy Sleep-disordered Breathing Gestational Diabetes

Interventions

CPAPDEVICE

Continuous Positive Airway Pressure

Nasal dilator stripOTHER

Nasal dilator strip to be worn nightly

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

McGill University Health Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Average nightly hours of CPAP use

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)

Time frame: Up to 8 weeks

Secondary Outcomes

Recruitment and retention rates in trial

Time frame: At completion of study (prior to delivery of baby)

Maternal glucose levels

Continuous glucose monitoring and capillary blood glucose checks

Time frame: Throughout pregnancy until delivery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.