A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this research study is to test a new approach for treating patients with obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway stent), appears to be a useful alternative or additive treatment.

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Detailed Description

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The nasal stent basically helps to splint the soft palate open. Subjects have a baseline (diagnostic) sleep study without wearing the device. Subjects are then fitted with the device and then subjects wear the device for at least 7 nights during their sleep while at home. Subjects then return for a repeat in-laboratory sleep study while wearing the device. The primary outcome is to assess the effectiveness of the device by change in the apnea-hypopnea index (number of sleep-related abnormal breathing events per hour of sleep) while wearing the device compared to baseline.

Conditions

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Obstructive Sleep Apnea Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nastent

Intervention Type DEVICE

Use of the device while at home and in the sleep lab

Interventions

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Nastent

Use of the device while at home and in the sleep lab

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults that are 18 years of age or older who had a prior sleep-study within the past 6 months that confirmed a diagnosis of obstructive sleep apnea, and with body mass index less than 30 kg/m2.

Exclusion Criteria

* Children, pregnant women, homeless, economically disadvantaged individuals, and those who are unable to comprehend or understand English, or follow instructions were excluded. Persons with body mass index equal or greater than 30 kg/m2 were excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes