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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial

Conditions
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Pregnancy, Sleep-disordered Breathing, Gestational Diabetes

Intervention / Treatment
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* Device: CPAP
* Other: Nasal dilator strip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br> | Device: CPAP<br>* Continuous Positive Airway Pressure<br>|
| Other: Nasal dilator strip<br>Control | Other: Nasal dilator strip<br>* Nasal dilator strip to be worn nightly<br>* Other names: Breathe-Right Strip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and retention rates in trial |  | At completion of study (prior to delivery of baby) | 
| Maternal glucose levels | Continuous glucose monitoring and capillary blood glucose checks | Throughout pregnancy until delivery |