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

Sleep Apnea, Obstructive Clinical Trial

— PANTHERA  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461417
• Other study ID #: PRO-140
• Status: Recruiting
• Start date: April 7, 2022
• Est. completion date: May 2028

Study information

• Verified date: February 2023
• Source: Panthera Dental Inc.
• Contact: Doris BARNIER-RIPET, MSc
• Phone: (33) 801 907 936
• Email: panthera[@]axonal.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 337
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (2)

Lead Sponsor	Collaborator
Panthera Dental Inc.	AXONAL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AHI evolution according to severity	AHI mean in global and in severity subgroups	Inclusion, 3 months, 2 years, 5 years
Secondary	Change in AHI	Difference between AHI at visit and at baseline	3 months, 2 years, 5 years
Secondary	Description of severity groups	Proportion of patients with AHI = 5, = 15 and = 30 at visit	Inclusion, 3 months, 2 years, 5 years
Secondary	Description of tiredness	Mean score of Pichot scale at each visit	Inclusion, 3 months, 2 years, 5 years
Secondary	Description of sleepiness	Mean score of Epworth scale at each visit	Inclusion, 3 months, 2 years, 5 years
Secondary	Description of snoring	Mean score of snoring measured by a Likert scale at each visit	Inclusion, 3 months, 2 years, 5 years
Secondary	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
Secondary	Satisfaction assessed by a Likert scale	Mean score of satisfaction measured by a Likert scale at each visit	3 months, 2 years, 5 years
Secondary	Oxygen Desaturation Index (ODI) evolution	Difference between ODI at visit and at baseline	3 months, 2 years, 5 years
Secondary	Minimal oxygen saturation (SpO2)	Minimum Spo2 at visit	Inclusion, 3 months, 2 years, 5 years
Secondary	Duration with SpO2<90%	Duration with SpO2<90%	Inclusion, 3 months, 2 years, 5 years
Secondary	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
Secondary	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
Secondary	Titration description	Rod length corresponding to optimal treatment	during titration