Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy

Pregnancy Related Clinical Trial

— OSApod  

Official title:

Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138291
• Other study ID #: OSApod
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2024
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 30, 2023
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Apnea
• Pregnancy Related
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Somnodent
Each pregnant women will be treat with a Somnodent

Locations

Country	Name	City	State
Canada	University of Montreal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obstructive sleep apnea	Apnea hypopnea index	9 months
Secondary	adherence	A mini-recorder will be use to see how many hours a day the patient wear the appliance.	9 months