At a glance
ClinicalIndex Comparison Record- ✓Nostril types I and II (inter-axial angle <41° for type I, 41–70° for type II)
- ✓Chronic nocturnal nasal congestion ('always or almost always') for at least the last year
- ✓Reports trouble with sleep
- ✕Known or suspected intolerance/hypersensitivity to latex or study materials; allergy to adhesive bandages
- ✕Chronic skin condition or eczema on face or nose
- ✕Visible open sores, sunburn, or irritation on face or nose immediately prior to treatment
- ✕Severe obstructive sleep apnea/hypopnea syndrome with AHI ≥30 events/hour at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Study of a Nasal Dilator Strip
In Brief
A Phase 2 clinical trial evaluating Prototype nasal dilator strip and No strip for Sleep Disordered Breathing and Congestion, Nasal. Completed, enrolled 91 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.