NCT02349893

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 19, 2022

Completed
Last Updated

July 19, 2022

Status Verified

June 1, 2022

Enrollment Period

6.4 years

First QC Date

January 24, 2015

Results QC Date

June 1, 2022

Last Update Submit

June 27, 2022

Conditions

Apnea, Sleep

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

RFA treatment

EXPERIMENTAL

RFA treatment performed with CelonProSleep plus device

Device: RFA treatment

Interventions

RFA treatmentDEVICE

RFA treatment using CelonProSleep plus system

RFA treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alessi Clinic

Beverly Hills, California, 90212, United States

Location

Otolaryngology Colorado

Greenwood Village, Colorado, 80909, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Bluesleep clinic

New York, New York, 10003, United States

Location

Institutional Review Board for Human Research (IRB)

Charleston, South Carolina, 29425-8570, United States

Location

Methodist Healthcare Foundation

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

This was a multicenter single-arm study. Further randomized controlled trails are needed to obtain higher level of evidence.

Results Point of Contact

Title
Dr Samuel Faran
Organization
Olympus Europa SE & Co. KG
samuel.faran@olympus.com
0049 1607168798

Study Officials

  • Shaun Nguyen, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2015

First Posted

January 29, 2015

Study Start

February 1, 2015

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 19, 2022

Results First Posted

July 19, 2022

Record last verified: 2022-06

Locations

US(6)