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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: D-SAD

• Study Type: Observational
• Enrollment (Anticipated): 337

Contacts and Locations

• Study Contact: Name: Doris BARNIER-RIPET, MSc; Phone Number: (33) 801 907 936; Email: panthera@axonal.com

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • CHU Angers
    • Contact: Fédéric GAGNADOUX, Prof; Phone Number: 33(0)241353695; Email: frgagnadoux@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
D-SAD group; Patients equipped with Panthera D-SAD MAO	Device: D-SAD; Patients equipped with Panthera D-SAD® orthosis will be recruited.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Panthera Dental Inc.
• Collaborators: AXONAL
• Investigators: Principal Investigator: Frédéric GAGNADOUX, Prof, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Anticipated): May 1, 2028
• Study Completion (Anticipated): May 1, 2028

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: snoring; Obstructive Sleep Apnea Hypopnea Syndrome (OSAS); Mandibular Advancement Orthosis; Panthera D-SAD
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PRO-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No