Sleep Apnea, ObstructiveOSApodNCT03138291
Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy
A study testing Somnodent in people with Sleep Apnea, Obstructive and Pregnancy Related, run by Université de Montréal at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Pregnancy Related
- What is being tested?
- Somnodent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Periodontal problems and untreated caries
- Poor dental hygiene
- Possible retention of OAM (Not enough teeth to retain the OAM in the mouth )
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Sleep Apnea, Obstructive, Pregnancy Related
- Being tested
- Somnodent
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomnodentDevice
Each pregnant women will be treat with a Somnodent
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Somnodent |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive sleep apnea
Apnea hypopnea index
Measured: 9 months
Secondary outcomes (1)
adherence
A mini-recorder will be use to see how many hours a day the patient wear the appliance.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startJun 2016
- Primary completionApr 2018
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
- Investigators
- Sushmita Pamidi, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138291
- Sponsor's protocol ID
- OSApod
- Acronym
- OSApod
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2016
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40183988Huynh 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.
PubMed 35829947
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Appliances on Obstructive Sleep Apnea During Pregnancy
- ClinicalTrials.gov ID
- NCT03138291
- Acronym / sponsor ID
- OSApod / OSApod
- Conditions
- Sleep Apnea, Obstructive, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somnodent | Experimental | Device: SomnodentSomnoDent 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomnodentEach pregnant women will be treat with a Somnodent | Device | Somnodent |
Primary outcome
obstructive sleep apnea
Time frame: 9 months
Apnea hypopnea index
1 secondary outcome
adherence
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 40183988Smocot 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.
- Derived from this study: PubMed 35829947Huynh 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushmita Pamidi, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnodent in people with Sleep Apnea, Obstructive and Pregnancy Related, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstructive sleep apnea (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.