A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | February 2015 |
| End Date: | December 31, 2017 |
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.
obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway
stent), appears to be a useful alternative or additive treatment.
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.
(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.
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.
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