Trial Outcomes & Findings for A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring (NCT NCT02928770)

Last Updated: 2019-01-15

Results Overview

Abnormal breathing events (apneas = complete pauses in oronasal airflow; hypopneas = decreases in oronasal airflow) per hour of sleep. This is measured through polysomnography (sleep study) by a nasal thermistor and oral pressure sensor.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

In-lab sleep study obtained at least 7 nights following use of the device at home

Results posted on

2019-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Nastent A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device. Nastent: Use of the device while at home and in the sleep lab
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Nastent A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device. Nastent: Use of the device while at home and in the sleep lab
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nastent n=30 Participants A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device. Nastent: Use of the device while at home and in the sleep lab
Age, Continuous	56.3 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Apnea-Hypopnea Index	34.9 events/hour STANDARD_DEVIATION 23.8 • n=5 Participants

PRIMARY outcome

Timeframe: In-lab sleep study obtained at least 7 nights following use of the device at home

Outcome measures

Outcome measures
Measure	Nastent n=30 Participants A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device. Nastent: Use of the device while at home and in the sleep lab
Apnea-Hypopnea Index (AHI)	30.0 events/hour Standard Deviation 20.3

Adverse Events

Nastent

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

Clete A. Kushida, M.D., Ph.D.

Stanford University

Phone: 6507217560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place