N/A
N=32
A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring
Obstructive Sleep Apnea · Snoring
Bottom Line
View on ClinicalTrials.gov: NCT02928770 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Apnea-Hypopnea Index (AHI) — 30.0 events/hour — p=0.0559
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nastent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-Hypopnea Index (AHI) |
30.0 | 0.0559 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02928770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.