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

Panthera Dental

Status: Active, not recruiting

Conditions: Sleep Apnea, Obstructive

Treatments: Device: D-SAD

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05461417

PRO-140

Details and patient eligibility

About

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.

Enrollment: 337 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

337 participants in 1 patient group

D-SAD group

Description:

Patients equipped with Panthera D-SAD MAO

Treatment:

Device: D-SAD