Clinical trial NCT05461417: Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea Hypopnea Syndrome (OSAS)
snoring
Mandibular Advancement Orthosis
Panthera D-SAD
Lead sponsor: Panthera Dental Inc.
Sponsor class: INDUSTRY
Collaborators: name: AXONAL
First posted: 2022-07-18
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years
timeFrame: At 5 years after treatment start
Secondary outcomes:
measure: AHI evolution according to severity
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Change in AHI
timeFrame: 3 months, 2 years, 5 years
measure: Description of severity groups
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Description of tiredness
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Description of sleepiness
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Description of snoring
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Quality of life assessed by Nottingham Health Profile (NHP) questionnaire
timeFrame: 3 months, 2 years, 5 years
measure: Satisfaction assessed by a Likert scale
timeFrame: 3 months, 2 years, 5 years
measure: Oxygen Desaturation Index (ODI) evolution
timeFrame: 3 months, 2 years, 5 years
measure: Minimal oxygen saturation (SpO2)
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Duration with SpO2<90%
timeFrame: Inclusion, 3 months, 2 years, 5 years
measure: Observance
timeFrame: Inclusion, 3 months, 2 years, 5 year
measure: Dental tolerance
timeFrame: Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years
measure: Titration description
timeFrame: during titration
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Frédéric GAGNADOUX, Prof
role: PRINCIPAL_INVESTIGATOR
References: