Trial Outcomes & Findings for Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study (NCT NCT02349893)

NCT ID: NCT02349893

Last Updated: 2022-07-19

Results Overview

The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 6 months following last treatment
• Results posted on: 2022-07-19

Participant Flow

Participant milestones

Measure	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)
Overall Study STARTED	56
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.

Baseline characteristics by cohort

Measure	RFA Treatment n=56 Participants 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)
Age, Customized Study completers	50.67 years STANDARD_DEVIATION 11.20 • n=43 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Age, Customized Study dropouts	53.75 years STANDARD_DEVIATION 8.18 • n=13 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Sex: Female, Male Study completers · Female	13 Participants n=43 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Sex: Female, Male Study completers · Male	30 Participants n=43 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Sex: Female, Male Study dropouts · Female	2 Participants n=13 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Sex: Female, Male Study dropouts · Male	11 Participants n=13 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=56 Participants
Race (NIH/OMB) Asian	0 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	4 Participants n=56 Participants
Race (NIH/OMB) White	44 Participants n=56 Participants
Race (NIH/OMB) More than one race	0 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=56 Participants
Apnea Hypopnea Index Study completers	19.70 No. of apneas/hypopneas per h of sleep STANDARD_DEVIATION 7.10 • n=43 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.
Apnea Hypopnea Index Study dropouts	19.15 No. of apneas/hypopneas per h of sleep STANDARD_DEVIATION 6.93 • n=13 Participants • Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.

PRIMARY outcome

Timeframe: 6 months following last treatment

Population: The apnea hypopnea index after the treatment was analyzed for all study completers.

The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.

Outcome measures

Measure	RFA Treatment n=43 Participants 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)
Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline	9.86 No. of apneas/hypopneas per h of sleep Standard Deviation 8.28

Adverse Events

RFA Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Samuel Faran

Olympus Europa SE & Co. KG

Phone: 0049 1607168798

Email: samuel.faran@olympus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place