Sleep Apnea Syndromes, ObstructiveNCT04367558
Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
A study testing Minimally invasive, in-office, RF reduction of the affected area in people with Sleep Apnea Syndromes, Obstructive, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Sleep Apnea Syndromes, Obstructive
- What is being tested?
- Minimally invasive, in-office, RF reduction of the affected area
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2020to 31 May 2022
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from OSA, defined as AHI > 5
Who cannot join
- Patients who can use CPAP.
- Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon)
- Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe MC,
Hadera, 38100
Itzhak Braverman, MD, 972-4-630-4549, braverman@hy.health.gov.il
Itzhak Braverman, MD
About this study
Official title: Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..
- Conditions
- Sleep Apnea Syndromes, Obstructive
- Being tested
- Minimally invasive, in-office, RF reduction of the affected area
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive, in-office, RF reduction of the affected areaProcedure or surgery
Usage of RF needle to treat one or more of the affected areas
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Patient suffering from OSA, and found to suffer from obstruction of one or more of the following areas - Lower turbines, Soft Palate, Tonsils, Base-of-tongue. Receives: Procedure: Minimally invasive, in-office, RF reduction of the affected area |
What is being measured
The primary outcome is the main question the study is designed to answer.
More than 50% improvement in Apnea-Hypopnea index (AHI)
Measuring the AHI score using sleep laboratory
Measured: 6 months following the procedure
More than 50% improvement in Apnea-Hypopnea index (AHI)
Measuring the AHI score using sleep laboratory
Measured: 12 months following the procedure
Reduction of AHI to below 20
Measuring the AHI score using sleep laboratory
Measured: 6 months following the procedure
Reduction of AHI to below 20
Measuring the AHI score using sleep laboratory
Measured: 12 months following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367558
- Sponsor's protocol ID
- 0010-20-HYMC
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT04367558
- Acronym / sponsor ID
- 0010-20-HYMC
- Conditions
- Sleep Apnea Syndromes, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 29 Apr 2020 (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 carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Minimally invasive, in-office, RF reduction of the affected areaPatient suffering from OSA, and found to suffer from obstruction of one or more of the following areas - Lower turbines, Soft Palate, Tonsils, Base-of-tongue. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from OSA, defined as AHI > 5
Key exclusion criteria (3 listed)
- Patients who can use CPAP.
- Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon)
- Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)
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 |
|---|---|---|
| Minimally invasive, in-office, RF reduction of the affected areaUsage of RF needle to treat one or more of the affected areas | Procedure or surgery | Interventional |
Primary outcome
More than 50% improvement in Apnea-Hypopnea index (AHI)
Time frame: 6 months following the procedure
Measuring the AHI score using sleep laboratory
More than 50% improvement in Apnea-Hypopnea index (AHI)
Time frame: 12 months following the procedure
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
Time frame: 6 months following the procedure
Measuring the AHI score using sleep laboratory
Reduction of AHI to below 20
Time frame: 12 months following the procedure
Measuring the AHI score using sleep laboratory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep Apnea Syndromes, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive, in-office, RF reduction of the affected area in people with Sleep Apnea Syndromes, Obstructive, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Itzhak Braverman, MD (972-4-7744664, braverman@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
More than 50% improvement in Apnea-Hypopnea index (AHI) (time frame: 6 months following the procedure). The study lists 4 primary outcomes in all. 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 27 May 2020.