Apnea, SleepNCT02349893
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
A study testing RFA treatment in people with Apnea, Sleep, run by Olympus Surgical Technologies Europe at 6 sites in United States.
Trial summary
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Apnea, Sleep
- What is being tested?
- RFA treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2015to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 22 years)
- Self-report of daytime somnolence
- Body mass index (BMI) ≤ 32
- Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
- Evidence of palate and tongue base collapse on supine fiberoptic examination
- Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (< 4 hours per night by patient report)
- No prior surgical treatment for OSAS other than nasal surgery
- Willing and capable of providing informed consent
Who cannot join
- Another significant sleep disorder (e.g., insomnia, periodic limb movement)
- Tonsillar hypertrophy
- Chronic Obstructive Pulmonary Disease (COPD)
- Interstitial Lung Disease (ILD)
- Cystic Fibrosis
- Acute Repiratory Distress Syndrome (ARDS)
Show all 25Show fewer
- Nasal or supraglottic obstruction on fiberoptic examination
- American Society of Anesthesiologists (ASA) class III ,IV, V
- Latex allergy
- Lidocaine allergy
- Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.
- Major depression or non-stabilized psychiatric disorder
- Drug or alcohol abuse
- Previous palatal or tongue surgery
- Stable or unstable angina
- congestive heart failure (CHF)
- moderate or severe valvular disease
- transient ischemic attack (TIA)/cardiovascular accident (CVA)
- Carotid stenosis or endarterectomy
- Anemia
- Room air oxygen saturation (SpO2) < 95%
- Pulmonary hypertension
- Dialysis
- Central or mixed apnea ≥ 10% of respiratory events
- Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
ENT of Georgia
Atlanta, Georgia, 30342
Alessi Clinic
Beverly Hills, California, 90212
Institutional Review Board for Human Research (IRB)
Charleston, South Carolina, 29425-8570
Otolaryngology Colorado
Greenwood Village, Colorado, 80909
Methodist Healthcare Foundation
Memphis, Tennessee, 38104
Bluesleep clinic
New York, New York, 10003
About this study
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.
This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).
- Conditions
- Apnea, Sleep
- Being tested
- RFA treatment
- 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.
RFA treatmentDevice
RFA treatment using CelonProSleep plus system
| Study group | Role | What they receive |
|---|---|---|
| RFA treatment | Experimental | RFA treatment performed with CelonProSleep plus device Receives: Device: RFA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Measured: 6 months following last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Apnea, SleepStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Surgical Technologies Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaun Nguyen, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349893
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2022
- First submitted
- 24 Jan 2015
- Last updated
- 19 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT02349893
- Acronym / sponsor ID
- 1
- Conditions
- Apnea, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Olympus Surgical Technologies EuropeIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.
This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA treatment | Experimental | Device: RFA treatmentRFA treatment performed with CelonProSleep plus device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (≥ 22 years)
- Self-report of daytime somnolence
- Body mass index (BMI) ≤ 32
- Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)
- Evidence of palate and tongue base collapse on supine fiberoptic examination
Key exclusion criteria (25 listed)
- Another significant sleep disorder (e.g., insomnia, periodic limb movement)
- Tonsillar hypertrophy
- Chronic Obstructive Pulmonary Disease (COPD)
- Interstitial Lung Disease (ILD)
- Cystic Fibrosis
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 |
|---|---|---|
| RFA treatmentRFA treatment using CelonProSleep plus system | Device | RFA treatment |
Primary outcome
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
Time frame: 6 months following last treatment
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shaun Nguyen, MD principal investigator
Medical University of South Carolina
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA treatment in people with Apnea, Sleep, run by Olympus Surgical Technologies Europe at 6 sites in United States.
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 8 inclusion and 25 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline (time frame: 6 months following last treatment). 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 19 Jul 2022.