Pregnancy, Sleep-disordered Breathing, Gestational Diabetes
Conditions
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.
Interventions
DEVICECPAP
Continuous Positive Airway Pressure
OTHERNasal dilator strip
Nasal dilator strip to be worn nightly
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Recruitment and retention rates in trial | At completion of study (prior to delivery of baby) | — |
| Maternal glucose levels | Throughout pregnancy until delivery | Continuous glucose monitoring and capillary blood glucose checks |
Countries
Canada
Outcome results
None listed