Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients. The Panthera D-SAD® is a computer aided design (CAD)/computer aided manufacturing (CAM), patient-matched, 3D printed, biocompatible nylon OAT. This five-year, observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD® orthosis on reducing the apnea hypopnea index (AHI) and obstructive sleep apnea-hypopnea syndrome (OSAHS) symptoms. Adherence, tolerance, and side effects will be evaluated. An estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of OAT, and struggles or refuses continuous positive airway (CPAP) treatment. The professional collaborative nature of the study reflects real-world clinical practice. Participants will be followed over the course of five years at the following time points. Visits include the following: Specialist in sleep disorders: (1) Inclusion, (2) 3 months, (3) 2 years, (4) 5 years. Specialist in manducatory apparatus (dentist): (1) Inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years The efficacy of the Panthera D-SAD® MAO will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial AHI, when monitored by nocturnal breathing polygraphy (NP) or polysomnography (PSG). Secondary endpoints will also be obtained at the aforementioned time points for reporting. The results of this study will fulfill regulatory requirements for reimbursement in France.

Official Title
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Non-comparative Prospective Study Evaluating the Long-term Efficacy, Tolerance and Compliance of the Panthera D-SAD Mandibular Advancement Orthosis in the Management of Obstructive Sleep Apnea Hypopnea Syndrome (PANTHERA Study)

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: D-SAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 Moderate OSAHS or severe OSAHS and refuse or intolerance to treatment with continuous positive pressure Patient who has never worn MAO Accepting and able to complete questionnaires in French on the impact of their disease and their quality of life Informed and having signed a written consent Affiliated to a social security system Exclusion Criteria: One or more contraindications to wearing a mandibular advancement orthosis Central sleep apnea Severe OSAHS associated with another sleep pathology Serious respiratory disorders other than OSAS Severe psychiatric or neurological disorders Progressive cancer and/or chronic joint, inflammatory or immunosuppressive disease Known allergy to one of the components of the medical device Simultaneous participation in another intervention research Vulnerable subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| D-SAD group<br>Patients equipped with Panthera D-SAD MAO | Device: D-SAD<br>* Patients equipped with Panthera D-SAD® orthosis will be recruited.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years | Proportion of patients with a reduction in AHI of 50% or more compared to inclusion, measured by polygraphy or somnopolygraphy | At 5 years after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI evolution according to severity | AHI mean in global and in severity subgroups | Inclusion, 3 months, 2 years, 5 years | 
| Change in AHI | Difference between AHI at visit and at baseline | 3 months, 2 years, 5 years | 
| Description of severity groups | Proportion of patients with AHI ≤ 5, ≤ 15 and ≤ 30 at visit | Inclusion, 3 months, 2 years, 5 years | 
| Description of tiredness | Mean score of Pichot scale at each visit | Inclusion, 3 months, 2 years, 5 years | 
| Description of sleepiness | Mean score of Epworth scale at each visit | Inclusion, 3 months, 2 years, 5 years | 
| Description of snoring | Mean score of snoring measured by a Likert scale at each visit | Inclusion, 3 months, 2 years, 5 years | 
| Quality of life assessed by Nottingham Health Profile (NHP) questionnaire | Mean score of Nottingham Health Profile (NHP) at each visit | 3 months, 2 years, 5 years | 
| Satisfaction assessed by a Likert scale | Mean score of satisfaction measured by a Likert scale at each visit | 3 months, 2 years, 5 years | 
| Oxygen Desaturation Index (ODI) evolution | Difference between ODI at visit and at baseline | 3 months, 2 years, 5 years | 
| Minimal oxygen saturation (SpO2) | Minimum Spo2 at visit | Inclusion, 3 months, 2 years, 5 years | 
| Duration with SpO2<90% | Duration with SpO2<90% | Inclusion, 3 months, 2 years, 5 years | 
| Observance | Number of nights equipped for a week, number of hours equipped for a night, percentage of patients equipped ≥4h per night | Inclusion, 3 months, 2 years, 5 year | 
| Dental tolerance | Number of device adverse reaction (DAR), proportion of patients with at least one DAR, number of incidents and deficiencies | Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years | 
| Titration description | Rod length corresponding to optimal treatment | during titration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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snoring, Obstructive Sleep Apnea Hypopnea Syndrome (OSAS), Mandibular Advancement Orthosis, Panthera D-SAD