Trial Outcomes & Findings for Pilot Study of cNEP for the Treatment of Snoring (NCT NCT02767843)

Results Overview

snoring decreased by \<50% from baseline

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

one night

Results posted on

2024-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Only four subjects completed the study.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of cNEP for the Treatment of Snoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=4 Participants continuous negative external pressure (cNEP) at various negative pressures continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: one night

Population: Technical problems with the measurement instruments meant that no analyzable data were collected.

snoring decreased by \<50% from baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: one night

Population: All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments.

all adverse events

Outcome measures

Outcome measures
Measure	Subjects n=4 Participants Only four subjects were entered into the study. None had outcome measure (2) collected because of technical problems with data collection. Thus no interpretable data were collected.
Adverse Events	1 Participants

SECONDARY outcome

Timeframe: one night

Population: Insufficient enrollment to permit analysis.

snoring for \< 5% of total sleep tim

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=4 participants at risk Only four subjects completed the study.
Skin and subcutaneous tissue disorders minor erythema	25.0% 1/4 • Number of events 1 • entire study duration

Additional Information

Jerrold Kram, MD

California Center for Sleep Disorders

Phone: 510.263.3300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place