NCT02928770

A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstructive Sleep Apnea
• Snoring

Interventions

Type	Name	Description
DEVICE	Nastent	Use of the device while at home and in the sleep lab

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2016-10-10
• Last updated: 2019-01-15
• Results posted: 2019-01-15

Locations

1 site across 1 country: United States