Apnea, Sleep
Conditions
Brief 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 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).
Interventions
DEVICERFA treatment
RFA treatment using CelonProSleep plus system
Sponsors
Olympus Surgical Technologies Europe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline | 6 months following last treatment | The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RFA Treatment RFA treatment performed with Celon ProSleep plus device, three treatment sessions of RF ablation of the soft palate (7 lesions) and the base of tongue (6 lesions) | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | RFA Treatment |
|---|---|
| Age, Customized Study completers | 50.67 years STANDARD_DEVIATION 11.2 |
| Age, Customized Study dropouts | 53.75 years STANDARD_DEVIATION 8.18 |
| Apnea Hypopnea Index Study completers | 19.70 No. of apneas/hypopneas per h of sleep STANDARD_DEVIATION 7.1 |
| Apnea Hypopnea Index Study dropouts | 19.15 No. of apneas/hypopneas per h of sleep STANDARD_DEVIATION 6.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Sex: Female, Male Study completers Female | 13 Participants |
| Sex: Female, Male Study completers Male | 30 Participants |
| Sex: Female, Male Study dropouts Female | 2 Participants |
| Sex: Female, Male Study dropouts Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
Primary
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline
The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.
Time frame: 6 months following last treatment
Population: The apnea hypopnea index after the treatment was analyzed for all study completers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RFA Treatment | Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline | 9.86 No. of apneas/hypopneas per h of sleep | Standard Deviation 8.28 |