Sleep Apnea, ObstructivePANTHERANCT05461417
Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Panthera Dental Inc. at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- D-SAD
- Type of treatment
- Medical device
- How many people
- 337 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2022to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Known allergy to one of the components of the medical device
- Simultaneous participation in another intervention research
- Vulnerable subjects
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- D-SAD
- Keywords
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAS), snoring, Mandibular Advancement Orthosis, Panthera D-SAD
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-SADDevice
Patients equipped with Panthera D-SAD® orthosis will be recruited.
| Study group | Role | What they receive |
|---|---|---|
| D-SAD group | Patients equipped with Panthera D-SAD MAO Receives: Device: D-SAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 5 years after treatment start
Secondary outcomes (14)
AHI evolution according to severity
AHI mean in global and in severity subgroups
Measured: Inclusion, 3 months, 2 years, 5 years
Change in AHI
Difference between AHI at visit and at baseline
Measured: 3 months, 2 years, 5 years
Description of severity groups
Proportion of patients with AHI ≤ 5, ≤ 15 and ≤ 30 at visit
Measured: Inclusion, 3 months, 2 years, 5 years
Description of tiredness
Mean score of Pichot scale at each visit
Measured: Inclusion, 3 months, 2 years, 5 years
Description of sleepiness
Mean score of Epworth scale at each visit
Measured: Inclusion, 3 months, 2 years, 5 years
Description of snoring
Mean score of snoring measured by a Likert scale at each visit
Measured: 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
Measured: 3 months, 2 years, 5 years
Satisfaction assessed by a Likert scale
Mean score of satisfaction measured by a Likert scale at each visit
Measured: 3 months, 2 years, 5 years
Oxygen Desaturation Index (ODI) evolution
Difference between ODI at visit and at baseline
Measured: 3 months, 2 years, 5 years
Minimal oxygen saturation (SpO2)
Minimum Spo2 at visit
Measured: Inclusion, 3 months, 2 years, 5 years
Duration with SpO2<90%
Duration with SpO2<90%
Measured: 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
Measured: 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
Measured: Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years
Titration description
Rod length corresponding to optimal treatment
Measured: during titration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start7 Apr 2022
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panthera Dental Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AXONAL
- Responsible party
- Sponsor
- Investigators
- Frédéric GAGNADOUX, Prof, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461417
- Sponsor's protocol ID
- PRO-140
- Acronym
- PANTHERA
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2022
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05461417
- Acronym / sponsor ID
- PANTHERA / PRO-140
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAS), snoring, Mandibular Advancement Orthosis, Panthera D-SAD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 337 participants (estimated)
- Lead sponsor
- Panthera Dental Inc.Industry (pharma, biotech, devices)
- Collaborators
- AXONAL
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-SAD group | – | Device: D-SADPatients equipped with Panthera D-SAD MAO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-SADPatients equipped with Panthera D-SAD® orthosis will be recruited. | Device | D-SAD group |
Primary outcome
Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years
Time frame: At 5 years after treatment start
Proportion of patients with a reduction in AHI of 50% or more compared to inclusion, measured by polygraphy or somnopolygraphy
14 secondary outcomes
AHI evolution according to severity
Time frame: Inclusion, 3 months, 2 years, 5 years
Change in AHI
Time frame: 3 months, 2 years, 5 years
Description of severity groups
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of tiredness
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of sleepiness
Time frame: Inclusion, 3 months, 2 years, 5 years
Description of snoring
Time frame: Inclusion, 3 months, 2 years, 5 years
Quality of life assessed by Nottingham Health Profile (NHP) questionnaire
Time frame: 3 months, 2 years, 5 years
Satisfaction assessed by a Likert scale
Time frame: 3 months, 2 years, 5 years
Oxygen Desaturation Index (ODI) evolution
Time frame: 3 months, 2 years, 5 years
Minimal oxygen saturation (SpO2)
Time frame: Inclusion, 3 months, 2 years, 5 years
Duration with SpO2<90%
Time frame: Inclusion, 3 months, 2 years, 5 years
Observance
Time frame: Inclusion, 3 months, 2 years, 5 year
Dental tolerance
Time frame: Inclusion, during titration, at 3 and 6 months then at 1, 2, 3, 4, 5 years
Titration description
Time frame: during titration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric GAGNADOUX, Prof principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Panthera Dental Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the MAO Panthera D-SAD® evaluated by the success rate of the treatment at 5 years (time frame: At 5 years after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.