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

• ClinicalTrials.gov Identifier: NCT02245659
• Recruitment Status: Completed
• First Posted: September 19, 2014
• Last Update Posted: February 17, 2021
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Information provided by (Responsible Party): Sushmita Pamidi, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information

• First Submitted Date: April 25, 2014
• First Posted Date: September 19, 2014
• Last Update Posted Date: February 17, 2021
• Study Start Date: March 2015
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 17, 2014)

Average nightly hours of CPAP use [ Time Frame: 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 17, 2014)

• Recruitment and retention rates in trial [ Time Frame: At completion of study (prior to delivery of baby) ]
• Maternal glucose levels [ Time Frame: Throughout pregnancy until delivery ]
  Continuous glucose monitoring and capillary blood glucose checks

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pregnancy
• Sleep-disordered Breathing
• Gestational Diabetes

Intervention

• Device: CPAP
  Continuous Positive Airway Pressure
• Other: Nasal dilator strip
  Nasal dilator strip to be worn nightly
  Other Name: Breathe-Right Strip

Study Arms

• Experimental: CPAP
  Intervention: Device: CPAP
• Nasal dilator strip
  Control
  Intervention: Other: Nasal dilator strip

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2021): 46
• Original Estimated Enrollment (submitted: September 17, 2014): 60
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02245659
• Other Study ID Numbers: RN-326488
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sushmita Pamidi, McGill University Health Centre/Research Institute of the McGill University Health Centre
• Original Responsible Party: Same as current
• Current Study Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Verification Date: February 2021