An observational study in Sleep Apnea, Obstructive, sponsored by Panthera Dental Inc.. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Panthera Dental Inc. · Observational
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 337 is above the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →This is the only study on the registry with Panthera Dental Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients equipped with Panthera D-SAD MAO
Device: D-SAD
Patients equipped with Panthera D-SAD® orthosis will be recruited.
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
Time frame: At 5 years after treatment start
AHI evolution according to severity
AHI mean in global and in severity subgroups
Time frame: Inclusion, 3 months, 2 years, 5 years
Change in AHI
Difference between AHI at visit and at baseline
Time frame: 3 months, 2 years, 5 years
Description of severity groups
Proportion of patients with AHI ≤ 5, ≤ 15 and ≤ 30 at visit
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of tiredness
Mean score of Pichot scale at each visit
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of sleepiness
Mean score of Epworth scale at each visit
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of snoring
Mean score of snoring measured by a Likert scale at each visit
Time frame: 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
Time frame: 3 months, 2 years, 5 years
Satisfaction assessed by a Likert scale
Mean score of satisfaction measured by a Likert scale at each visit
Time frame: 3 months, 2 years, 5 years
Oxygen Desaturation Index (ODI) evolution
Difference between ODI at visit and at baseline
Time frame: 3 months, 2 years, 5 years
Minimal oxygen saturation (SpO2)
Minimum Spo2 at visit
Time frame: Inclusion, 3 months, 2 years, 5 years
Duration with SpO2<90%
Duration with SpO2\<90%
Time frame: 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
Time frame: 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
Time frame: Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years
Titration description
Rod length corresponding to optimal treatment
Time frame: during titration
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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