Trial Outcomes & Findings for Sleep Apnea Treatment With Expiratory Resistance(Provent™) (NCT NCT01061476)

Results Overview

The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI \> 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and \> 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Comparisons were made between the 2 nights

Results posted on

2013-07-19

Participant Flow

The study was conducted between 2010 and 2011. Patients were primarily recruited from the JH Sleep Disorders Center with a NREM RDI \>= 10/h and \>=90% of events were considered obstructive. 17 subjects met eligibility criteria with 12 enrolled.

Subjects were brought in for an evaluation prior to study enrollment to see if they would tolerate the Provent device by lying down with the device in place for 15-20 minutes.

Participant milestones

Participant milestones
Measure	Single Arm - Sleep Apnea All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep. Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm - Sleep Apnea n=12 Participants All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep. Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	48.3 years STANDARD_DEVIATION 18.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Comparisons were made between the 2 nights

Population: Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.

The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI \> 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and \> 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).

Outcome measures

Outcome measures
Measure	Single Arm - Sleep Apnea n=11 Participants Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep. Participants did not use Provent™ outside of the sleep laboratory. Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive.
Change in AHI Baseline AHI	45 events/h Standard Deviation 38
Change in AHI Change in AHI	-15.8 events/h Standard Deviation 18.02

Adverse Events

Single Arm - Sleep Apnea

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. Susheel Patil

Johns Hopkins University

Phone: 410-550-0574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60