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

NCT ID: NCT02245659

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Pregnancy; Sleep-disordered Breathing; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Continuous Positive Airway Pressure

Nasal dilator strip

Control

Group Type: OTHER

Nasal dilator strip

Intervention Type: OTHER

Nasal dilator strip to be worn nightly

Interventions

CPAP

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Nasal dilator strip

Nasal dilator strip to be worn nightly

Intervention Type: OTHER

Other Intervention Names

Breathe-Right Strip

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Sushmita Pamidi

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

References

Smocot J, Huynh N, Panyarath P, Kimoff RJ, Meltzer S, Drouin-Gagne L, Newbold R, Hebert C, Benedetti A, Arcache JP, Morency AM, Garfield N, Rey E, Pamidi S. Patterns of adherence to continuous positive airway pressure and mandibular advancement splints in pregnant individuals with sleep-disordered breathing. Sleep Breath. 2025 Apr 4;29(2):148. doi: 10.1007/s11325-025-03284-5.

Reference Type: DERIVED

PMID: 40183988 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30505290 (View on PubMed)

Other Identifiers

RN-326488

Identifier Type: -

Identifier Source: org_study_id