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

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; Gestational Diabetes; Sleep-disordered Breathing
• Intervention / Treatment: Device: CPAP; Other: Nasal dilator strip

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A2Y3
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Pregnancy Complications; Sleep Apnea Syndromes; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: RN-326488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO