obstructief slaapapneu Sleep apnea Snoring
Conditions
Interventions
Study procedures
• After patient inclusion, a baseline portable sleep monitoring at home
(WatchPAT*300) for 2 consecutive nights will be performed.
• During the next visit the objective size and posi
Sponsors
Nastent, inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 18 AHI
Exclusion criteria
Exclusion criteria: - Craniofacial deformities - Acute nasal trauma, fracture (during past 3 months) - Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis - Cerebrospinal fluid leaks - History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia20 alcohol units/week or any use of hard drugs) - Sleep medication use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the efficacy of Nastent R in treatment of snoring and/or OSA by use of the RDI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Epworth sleepiness scale score (ESS), Mean SaO2 (SaO2), AHI, ODI (oxygen desaturation index), VAS (visual analogue scale) for snoring as reported by the partner and evaluation of symptoms. | — |
Countries
Netherlands
Outcome results
None listed