A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

NCT02928770 | Completed Results

• 1 other identifier: 32492
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Snoring

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  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.

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

Study Arms (1)

Nastent

EXPERIMENTAL

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.

Device: Nastent

Interventions

Nastent DEVICE

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

Nastent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Seven Dreamers Laboratories: collaborator

Study Sites (1)

Stanford Sleep Medicine

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clete A. Kushida, M.D., Ph.D.
• Organization: Stanford University

clete@stanford.edu

6507217560

Study Officials

• Clete A Kushida, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director/Clinic Chief

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: February 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)