NCT02245659

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

April 25, 2014

Last Update Submit

February 15, 2021

Conditions

PregnancySleep-disordered BreathingGestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Recruitment and retention rates in trial

    At completion of study (prior to delivery of baby)

  • Maternal glucose levels

    Throughout pregnancy until delivery

Study Arms (2)

CPAP

EXPERIMENTAL
Device: CPAP

Nasal dilator strip

OTHER

Control

Other: Nasal dilator strip

Interventions

CPAPDEVICE

Continuous Positive Airway Pressure

CPAP
Nasal dilator stripOTHER

Nasal dilator strip to be worn nightly

Also known as: Breathe-Right Strip
Nasal dilator strip

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A2Y3, Canada

Location

Related Publications (2)

  • 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.

    PMID: 40183988DERIVED

  • 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.

    PMID: 30505290DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesDiabetes, Gestational

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 25, 2014

First Posted

September 19, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)