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

NCT05461417 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PRO-140
• Study Type: observational
• Target: 337
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea Hypopnea Syndrome (OSAS); snoring; Mandibular Advancement Orthosis; Panthera D-SAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• AHI evolution according to severity

  Inclusion, 3 months, 2 years, 5 years

• Change in AHI

  3 months, 2 years, 5 years

• Description of severity groups

  Inclusion, 3 months, 2 years, 5 years

• Description of tiredness

  Inclusion, 3 months, 2 years, 5 years

• Description of sleepiness

  Inclusion, 3 months, 2 years, 5 years

Study Arms (1)

D-SAD group

Patients equipped with Panthera D-SAD MAO

Device: D-SAD

Interventions

D-SAD DEVICE

Patients equipped with Panthera D-SAD® orthosis will be recruited.

D-SAD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from moderate sleep apnea, or severe sleep apnea with refusal or failure of CPAP treatment and meeting the eligibility criteria may participate in this observational study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panthera Dental Inc.: lead
• AXONAL: collaborator

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric GAGNADOUX, Prof

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 18, 2022
• Study Start: April 7, 2022
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)