Snoring R06.5
Conditions
Interventions
Group 1: In the first polysomnography night out of two, with in-active pillow, in the second with active pillow. Adaptation as well as subjective Trial period at home were ot randomised.
Group 2: In t
Sponsors
Sissel GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients / participants with primary snoring (Obstructive sleep apnea was ruled out previous to the study by polysomnography or respiratory polygraphy) aged between 18 and 75 body mass index (BMI) <= 30 without daytime sleepiness and an existing bed partner
Exclusion criteria
Exclusion criteria: Aged 75 BMI>30 obstructive sleep apnea or persistent daytime sleepiness (ESS>12)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appearance of snoring reduction: The appearance of snoring reduction will be determined by a visual analogue scale, that test person and bed partner are going to fill out prior to study start, as well as after completion of the on month lasting test and settling-in period. Furthermore the snoring – index is taking into consideration, which will be ascertained during the two polysomnography nights in the sleep laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Alteration of sleep quality: During the settling-in period, questions on “falling asleep easily”, “lying down and sleeping as usual”, “being tired the next morning, exhausted, irritable“, “being disturbed by the pillow while sleeping“ and “sleeping through“ has to be answered after each night for evaluating the sleep quality. Further on questionnaires regarding daytime sleepiness via ESS (Epworth Sleepiness Scale) and sleep quality will be handed over prior to study start and afterwards. Evaluation of the polysomnographic sleep- and breath-related parameters, like AHI (apnea-hypopnea-Index), AHI in supine position, RERAS (Respiratory Effort-Related Arousals). | — |
Countries
Germany
Contacts
Public ContactJoachim T. Maurer
Universitäts-HNO-KlinikSchlafmedizinisches Zentrum
Outcome results
None listed