NCT03138291

Brief Summary

Issue: The prevalence and severity of sleep-disordered breathing increases during pregnancy due to weight gain, physiological and hormonal changes. These sleep breathing disorders have a negative impact on perinatal health for both the mother and the child.The optimal treatment of obstructive sleep apnea in pregnancy is unknown. Although CPAP therapy is often the treatment of choice, the mandibular advancement appliance would be an interesting alternative to solve the matter. Objectives: The main objective of this pilot study is to evaluate the feasibility of mandibular advancement device to treat sleep apnea during the 2nd and 3rd trimesters of pregnancy. Secondary objectives will be tools to plan a future randomized controlled trial to determine the efficacy of this treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

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

March 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

March 15, 2016

Last Update Submit

March 27, 2024

Conditions

Sleep Apnea, ObstructivePregnancy Related

Outcome Measures

Primary Outcomes (1)

  • obstructive sleep apnea

    Apnea hypopnea index

    9 months

Secondary Outcomes (1)

  • adherence

    9 months

Study Arms (1)

Somnodent

EXPERIMENTAL

SomnoDent is a custom-made oral appliance for the treatment of mild to moderate obstructive sleep apnea. SomnoDent is worn during sleep to provide Continuous Open Airway Therapy by moving the lower jaw slightly forward. This movement tightens the soft tissue and muscles of the upper airway, which prevents obstructive apneas while sleeping.

Device: Somnodent

Interventions

SomnodentDEVICE

Each pregnant women will be treat with a Somnodent

Somnodent

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult women (≥ 18 years old)
  • Pregnant women (between14 and 34 weeks)
  • Sleep apnea with respiratory disturbance index (RDI) ≥ 5 events/hour
  • Snoring or sleep apnea testimony by chamber partner

You may not qualify if:

  • Severe sleep apnea
  • Evidence of a respiratory sleep disorder other than sleep apnea
  • Body mass index greater than 40
  • Use of medication that could affect breathing or sleep
  • Abnormalities of the upper airway (oversized amygdala)
  • Severe temporomandibular disorder
  • Periodontal problems and untreated caries
  • Poor dental hygiene
  • Possible retention of OAM (Not enough teeth to retain the OAM in the mouth )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Montreal

Montreal, Quebec, h3v 1h9, 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

  • Huynh N, Drouin-Gagne L, Gilbert C, Arcache JP, Rompre P, Morency AM, Gagnon R, Kimoff J, Pamidi S. Adherence and efficacy of mandibular advancement splint treatment of sleep-disordered breathing during pregnancy: a pilot study. Sleep Breath. 2023 Jun;27(3):869-877. doi: 10.1007/s11325-022-02681-4. Epub 2022 Jul 13.

    PMID: 35829947DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sushmita Pamidi, MD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2016

First Posted

May 3, 2017

Study Start

June 1, 2016

Primary Completion

April 1, 2018

Study Completion

March 30, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations

CA(1)