Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349893
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date June 30, 2021

Study information

Verified date June 2022
Source Olympus Surgical Technologies Europe
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


Read more »

Study Design


Intervention

Device:
RFA treatment
RFA treatment using CelonProSleep plus system

Locations

Country Name City State
United States ENT of Georgia Atlanta Georgia
United States Alessi Clinic Beverly Hills California
United States Institutional Review Board for Human Research (IRB) Charleston South Carolina
United States Otolaryngology Colorado Greenwood Village Colorado
United States Methodist Healthcare Foundation Memphis Tennessee
United States Bluesleep clinic New York New York

Sponsors (1)

Lead Sponsor Collaborator
Olympus Surgical Technologies Europe

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 6 months following last treatment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04326634 - Controlled Exercises Effectiveness in Patients With Sleep Apnea N/A
Completed NCT02898792 - Remifentanil in Adults With OSA Early Phase 1
Active, not recruiting NCT04861038 - Study Using Negative Pressure to Reduce Apnea N/A
Completed NCT00252629 - Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment N/A
Completed NCT01092780 - Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010) Phase 1
Completed NCT03033901 - Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome
Completed NCT03034447 - Sleep Apnea in Asthmatic Children and Teenagers N/A
Completed NCT03172806 - Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients
Completed NCT02886156 - Effects of CPAP on Cognitive Function, Neurocognitive Architecture and Function in Patients With OSA: The SMOSAT Trial N/A