Reduction of Initial AHINCT02094482
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
A study testing The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. in people with Reduction of Initial AHI and Reduction of Initial Snoaring Index, run by Medartis AG at 1 site in Switzerland.
Trial summary
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Initial AHI, Reduction of Initial Snoaring Index
- What is being tested?
- The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Study patients must meet all of the following inclusion criteria:
- Socially disturbing snoring with/without obstructive sleep apnea syndrome
- Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
- Findings for predominantly retropalatal obstructions in ENT-examination:
- No tonsils or tonsils grade I - II
- Normal finding of larynx and tongue base
Show all 12Show fewer
- No lingual tonsil hypertrophy
- ASA (American Society of Anaesthesiology, 1963) criteria I or II
- Body mass index (BMI) < 33 kg/m2
- Age > 18 yrs
- Fix bed partner
- Ability to read and understand the patient's information
Who cannot join
- Previous Pillar implants
- Previous airway surgery other than nasal, adenoid, tonsil or UPPP
- Presence of other sleep disorders
- Psychiatric disorders
- Neurological disorders (e.g. Cerebrovascular injury)
- Dysmorphia of the cranial skeleton
Show all 9Show fewer
- Pregnancy or breastfeeding
- Known hypersensitivity to nitinol
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Read the detailed description
The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.
The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.
Study hypothesis: Reduction of initial AHI ≥20%
- Being tested
- The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.Device
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate
| Study group | Role | What they receive |
|---|---|---|
| OSAS Palatal Implant | Other | The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate . Receives: Device: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of initial AHI by ≥20%
The primary endpoint is the Apnea-Hypopnea-Index (AHI) at the 90 days follow-up.
Study hypothesis: Reduction of initial AHI ≥20%. AHI is measured using cardio-respiratory polygraphy. Two measurements are performed before treatment and at 90 days follow-up in order to reduce effects from night-to-night variability.
Measured: 90days
Secondary outcomes (1)
Reduction of initial snoring index ≥30%
Endpoint snoring is measured on a continuous Visual Analog Scale (VAS) by the bed partner.
Study hypothesis: Reduction of initial snoring index ≥30%
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Initial AHIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medartis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Tschopp, MD, Principal investigator, Kantonsspital Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094482
- Sponsor's protocol ID
- P08138.1
- Status last verified
- Sep 2021
- First submitted
- 20 Mar 2014
- Last updated
- 13 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
- ClinicalTrials.gov ID
- NCT02094482
- Acronym / sponsor ID
- P08138.1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medartis AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 21 Mar 2014 (estimated)
- 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.
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Detailed description
The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.
The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.
Study hypothesis: Reduction of initial AHI ≥20%
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAS Palatal Implant | Other | Device: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Socially disturbing snoring with/without obstructive sleep apnea syndrome
- Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
- Findings for predominantly retropalatal obstructions in ENT-examination:
- No tonsils or tonsils grade I - II
- Normal finding of larynx and tongue base
Key exclusion criteria (9 listed)
- Previous Pillar implants
- Previous airway surgery other than nasal, adenoid, tonsil or UPPP
- Presence of other sleep disorders
- Psychiatric disorders
- Neurological disorders (e.g. Cerebrovascular injury)
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 |
|---|---|---|
| The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate | Device | OSAS Palatal Implant |
Primary outcome
Reduction of initial AHI by ≥20%
Time frame: 90days
The primary endpoint is the Apnea-Hypopnea-Index (AHI) at the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20%. AHI is measured using cardio-respiratory polygraphy. Two measurements are performed before treatment and at 90 days follow-up in order to reduce effects from night-to-night variability.
1 secondary outcome
Reduction of initial snoring index ≥30%
Time frame: 90days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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.
Kurt Tschopp, MD principal investigator
Kantonsspital Liestal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. in people with Reduction of Initial AHI and Reduction of Initial Snoaring Index, run by Medartis AG at 1 site in Switzerland.
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 12 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: finished, as of the sponsor's last update on 13 Sep 2021. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of initial AHI by ≥20% (time frame: 90days). 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 Sep 2021.