Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02245659|
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Sleep-disordered Breathing Gestational Diabetes||Device: CPAP Other: Nasal dilator strip||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Continuous Positive Airway Pressure
Nasal dilator strip
Other: Nasal dilator strip
Nasal dilator strip to be worn nightly
Other Name: Breathe-Right Strip
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245659
|Contact: Sushmita Pamidi, MD||514-934-1934 ext firstname.lastname@example.org|
|McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada, H4A2Y3|
|Principal Investigator: Sushmita Pamidi, MD|