A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Nastent	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.

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	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.

Secondary Outcome Measures