Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy (OSApod)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Pregnancy Related
• Intervention / Treatment: Device: Somnodent

Detailed Description

Study design : Intervention Pilot Study uncontrolled experimental cohort

Population: 32 pregnant women with sleep apnea with an apnea - hypopnea index ( AHI ) ≥ 10 events / hr .

Methodology: The mandibular advancement appliance will be used with the chip DentiTracs to measure adhesion. Participation in this project requires five visits to the research team, including 3 visits at home. Participants will be recruited and granted in obstetrics MUHC. The questionnaires will be filled (Epworth Sleepiness Scale, Pittsburgh sleep quality and functional (FOSQ)). A sleep recording (PSG type II) will be done at home to confirm the diagnosis. The recording equipment will be returned to the research team by mail. During the second visit (clinical orthodontics), dental impressions in alginate will be made. At the 3rd visit (clinical orthodontics), the mandibular advancement appliance will be adjusted and instructions will be given. A weekly phone call follow-up will be ensured during this period of adjustment of the appliance. The fourth visit (at home) will consist of a sleep recording to evaluate the effect of treatment. A questionnaire comfort / secondary effects will be administered. For patients who have started their participation during their second trimester, a sleep recording at home (4a visit) will be realized in Q3 to assess whether it is necessary to change the titration of the appliance. The 5th visit (orthodontic clinic) will be 3-6 months after delivery. Participants will fulfill all the mentioned questionnaires and make a sleep recording at home without the appliance. Replace the appliance in place if AHI> 10. During the 4th and 5th visits, anthropometric data (ie, weight), and objective adhesion will be taken

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, h3v 1h9
      • University of Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

INCLUSION CRITERIA

• 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

EXCLUSION CRITERIA

• 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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somnodent; 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; Each pregnant women will be treat with a Somnodent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obstructive sleep apnea	Apnea hypopnea index	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence	A mini-recorder will be use to see how many hours a day the patient wear the appliance.	9 months

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Sushmita Pamidi, MD, McGill University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: April 30, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: OSApod

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No