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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245659
• Other study ID #: RN-326488
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy
• Sleep Apnea Syndromes
• Sleep-disordered Breathing

Intervention

Device:
• CPAP
Continuous Positive Airway Pressure

Other:
• Nasal dilator strip
Nasal dilator strip to be worn nightly

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment and retention rates in trial		At completion of study (prior to delivery of baby)
Secondary	Maternal glucose levels	Continuous glucose monitoring and capillary blood glucose checks	Throughout pregnancy until delivery