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Behavioural Intervention

Somnyx ® for Obstructive Sleep Apnea (SOMNYX Trial)

N/A
Waitlist Available
Led By Nelly Huynh, PhD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following 3 months of treatment
Awards & highlights

SOMNYX 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). 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.

Eligible Conditions
  • Obstructive Sleep Apnea

SOMNYX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following 3 months of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and following 3 months of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Desaturation
Fatigue
Partial response rate
+7 more

SOMNYX Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Somnyx ®Experimental Treatment1 Intervention
Active mandibular advancement splint (Somnyx ®)
Group II: Narval ORM ® or SomnoDent ®Active Control1 Intervention
Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somnyx ®
2014
N/A
~100

Find a Location

Who is running the clinical trial?

University Hospital, MontpellierOTHER
1,197 Previous Clinical Trials
19,213,510 Total Patients Enrolled
Université de MontréalLead Sponsor
214 Previous Clinical Trials
102,671 Total Patients Enrolled
Groupe Hospitalier Pitie-SalpetriereOTHER
100 Previous Clinical Trials
2,013,241 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Apr 2025