Clinical trial NCT02245659: Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Official title: The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sleep-disordered Breathing
Gestational Diabetes
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Average nightly hours of CPAP use
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Recruitment and retention rates in trial
timeFrame: At completion of study (prior to delivery of baby)
measure: Maternal glucose levels
timeFrame: Throughout pregnancy until delivery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References:
citation: Pamidi S, Meltzer SJ, Garfield N, Lavigne L, Olha A, Khalyfa A, Benedetti A, Tremblay G, Gagnon R, Rey E, Dasgupta K, Kimoff RJ. A Pilot Randomized-Controlled Trial on the Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: Study Design and Methods. Front Endocrinol (Lausanne). 2018 Nov 16;9:659. doi: 10.3389/fendo.2018.00659. eCollection 2018.