Sleep Disordered Breathing Clinical Trial
Official title:
An Exploratory Study of a Nasal Dilator Strip
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.
This study was a baseline-controlled study. This study consisted of three phases: Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), and at Day 30 and 31 (Night 30 and 31 of Nasal resistance phase). Participants wore the Nasal dilator strip during Active phase. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 30 and 31 (Night 30 and 31) where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip" as per there randomization schedule. ;
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