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

Not Applicable

Completed

• Conditions: Pregnancy; Gestational Diabetes; Sleep-disordered Breathing
• Interventions: Other: Nasal dilator strip; Device: CPAP

• Registration Number: NCT02245659
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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 Timeline

• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Study Start: 2015-03
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal dilator strip	Nasal dilator strip	Control
CPAP	CPAP	-

Primary Outcome Measures

Name	Time	Method
Average nightly hours of CPAP use	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

Name	Time	Method
Maternal glucose levels	Throughout pregnancy until delivery	Continuous glucose monitoring and capillary blood glucose checks
Recruitment and retention rates in trial	At completion of study (prior to delivery of baby)

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada