Obstructive Sleep ApneaSOMNYXNCT02112435
Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea
A study testing Somnyx ® and Narval ORM ® or SomnoDent ® in people with Obstructive Sleep Apnea, run by Université de Montréal at 3 sites in 2 countries.
Trial summary
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Somnyx ® and Narval ORM ® or SomnoDent ®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2014to Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30
- patient in failure or refusal of CPAP treatment
- agree to participate and sign the consent form research
- speak and understand French without external assistance
- be in good health (no neurological or psychiatric syndrome).
- have a valid Social Security card (in France and Portugal only)
Who cannot join
- contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
- dental restorations in progress or planned in the next 6 months
- psychiatric and neuromuscular disorders
- untreated cardiovascular diseases and history of stroke or myocardial infarction
- severe or morbid obesity (body mass index> 35)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Université Montpellier
Montpellier
Groupe Hospitalier Pitie-Salpetriere
Paris
About this study
Official title: Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Somnyx ®, Narval ORM ® or SomnoDent ®
- Keywords
- obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance
- 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.
Somnyx ®Device
Also called Active mandibular advancement appliance, Oral appliance
Active mandibular advancement splint
Narval ORM ® or SomnoDent ®Device
Also called Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning appliance
Mandibular advancement splint
| Study group | Role | What they receive |
|---|---|---|
| Narval ORM ® or SomnoDent ® | Active comparator | Mandibular advancement splint (Narval ORM ® or SomnoDent ®) Receives: Device: Narval ORM ® or SomnoDent ® |
| Somnyx ® | Experimental | Active mandibular advancement splint (Somnyx ®) Receives: Device: Somnyx ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night
Measured: following 3 months of treatment
Secondary outcomes (10)
Rate of Complete Response
Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)
Measured: following 3 months of treatment
Partial response rate
Partial response rate =% of patients with reduction AHI ≥ 50% with AHI> 15 or AHI <15 with reduction <50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.
Measured: Following 3 months of treatment
Subjective compliance
Subjective compliance
Measured: Following 3 months of treatment
Sleep quality
sleep efficiency, total sleep time
Measured: Following 3 months of treatment
Desaturation
desaturation index, time spent below 90%
Measured: Following 3 months of treatment
Subjective sleep
Pittsburgh questionnaire
Measured: Following 3 months of treatment
Quality of life
Functional outcomes sleep questionnaire (FOSQ)
Measured: Following 3 months of treatment
Fatigue
Chalder fatigue questionnaire
Measured: Following 3 months of treatment
Subjective daytime sleepiness
Epworth sleepiness score
Measured: Following 3 months of treatment
Side effects
side effects and interactions with the dental evaluations
Measured: Following 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
- Investigators
- Nelly Huynh, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112435
- Sponsor's protocol ID
- 14-011-CERES-D
- Other IDs
- NH-14SRP-Somnyx
- Acronym
- SOMNYX
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2014
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02112435
- Acronym / sponsor ID
- SOMNYX / 14-011-CERES-D
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, University Hospital, Montpellier
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Apr 2014 (estimated)
- 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.
Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narval ORM ® or SomnoDent ® | Active comparator | Device: Narval ORM ® or SomnoDent ®Mandibular advancement splint (Narval ORM ® or SomnoDent ®) |
| Somnyx ® | Experimental | Device: Somnyx ®Active mandibular advancement splint (Somnyx ®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 18 and 65 years
- severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30
- patient in failure or refusal of CPAP treatment
- agree to participate and sign the consent form research
- speak and understand French without external assistance
Key exclusion criteria (5 listed)
- contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
- dental restorations in progress or planned in the next 6 months
- psychiatric and neuromuscular disorders
- untreated cardiovascular diseases and history of stroke or myocardial infarction
- severe or morbid obesity (body mass index> 35)
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 |
|---|---|---|
| Somnyx ®Also: Active mandibular advancement appliance, Oral applianceActive mandibular advancement splint | Device | Somnyx ® |
| Narval ORM ® or SomnoDent ®Also: Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning applianceMandibular advancement splint | Device | Narval ORM ® or SomnoDent ® |
Primary outcome
Overall response rate
Time frame: following 3 months of treatment
Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night
10 secondary outcomes
Rate of Complete Response
Time frame: following 3 months of treatment
Partial response rate
Time frame: Following 3 months of treatment
Subjective compliance
Time frame: Following 3 months of treatment
Sleep quality
Time frame: Following 3 months of treatment
Desaturation
Time frame: Following 3 months of treatment
Subjective sleep
Time frame: Following 3 months of treatment
Quality of life
Time frame: Following 3 months of treatment
Fatigue
Time frame: Following 3 months of treatment
Subjective daytime sleepiness
Time frame: Following 3 months of treatment
Side effects
Time frame: Following 3 months of treatment
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 29 Mar 2024.
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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.
Nelly Huynh, PhD principal investigator
Université de Montréal
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnyx ® and Narval ORM ® or SomnoDent ® in people with Obstructive Sleep Apnea, run by Université de Montréal at 3 sites in 2 countries.
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 7 inclusion and 5 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 29 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 3 sites in France, 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?
Overall response rate (time frame: following 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.