Continuous Negative External Pressure for the Treatment of Primary Snoring
| Status: | Suspended |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 6/22/2018 |
| Start Date: | January 29, 2018 |
| End Date: | July 2019 |
Continuous Negative External Pressure (cNEP) for the Treatment of Primary Snoring: A Pilot Study
The aim of this pilot study is to gain information on the ability of a continuous negative
external pressure collar to safely reduce snoring in primary snorers, and if so to determine
whether the reduction in snoring has benefits for both the snorer and the bed partner. This
clinical trial will involve both the snorer and his or her bed partner, both of whom must
qualify and provide informed consent for participation.
external pressure collar to safely reduce snoring in primary snorers, and if so to determine
whether the reduction in snoring has benefits for both the snorer and the bed partner. This
clinical trial will involve both the snorer and his or her bed partner, both of whom must
qualify and provide informed consent for participation.
Key Snorer Inclusion Criteria:
- BMI <35
- if a previously done polysomnogram (PSG) is available, AHI<5
- snoring identified by a previous PSG and/or by the bed partner
Key bed partner Inclusion criteria
- must have regularly slept with the snorer over the previous month and must plan to
sleep with the snorer for the duration of the trial
- considers that the snorer's snoring is a problem
- must discontinue use of any snore-masking equipment or ear plug for at least two weeks
prior to the initial visit to the study site and agree to refrain from their use for
the duration of the trial
Key snorer exclusion criteria:
- sleep disturbance other than snoring
- snoring due primarily to abnormality of the nasopharynx
- use of snoring treatment during the month prior to the initial visit
- neck anatomic or skin abnormalities
- serious medical condition
- excessive drug or alcohol intake
Key bed partner exclusion criteria:
-known sleep disorder
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