Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AXONAL | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-SAD group | Patients equipped with Panthera D-SAD MAO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-SAD | Device | Patients equipped with Panthera D-SAD® orthosis will be recruited. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frédéric GAGNADOUX, Prof | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |