A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

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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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Sleep Medicine

Redwood City, California, 94063, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nastent

Device

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

Primary outcomes

Apnea-Hypopnea Index (AHI)

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

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

Seven Dreamers Laboratories

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Oct 10, 2016
Registry last updated: Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed