To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sl… (NCT03105297) | Clinical Trial Compass
CompletedPhase 2
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.
Australia91 participantsStarted 2009-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
* Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
* Sleep: Reports trouble with sleep
Exclusion Criteria:
* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
* Subject has a chronic skin condition or eczema on the face or nose.
* Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
* Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score \<30 events/hour at the Baseline visit.
* Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping \>2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
* Subject has a non-typical sleep schedule (e.g. shift-work).
* Subject plans travel involving time-zone changes during the study period.
* Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioi…
What they're measuring
1
Nasal Resistance in Sleeping State : Nasal Resistance Phase
Timeframe: upto 2 days
2
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Timeframe: Day 1
3
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Timeframe: Day 1
4
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase