Clinical trial NCT03105297: 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.
Official title: An Exploratory Study of a Nasal Dilator Strip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disordered Breathing
Congestion, Nasal
Keywords: Nasal dilator strip
Sleep disordered breathing
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-04-07
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study consisted of 3 phases baseline and active phase in which participants used the nasal dilator strip followed by 2 nights cross over nasal resistance phase in which participants were randomized to receive a sequence of strip/no strip or no strip/strip.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.
* Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.
* Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.
* Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
* Subject has a positive drug of abuse screening result.
* Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.
* Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.
* Subject is unwilling to be videotaped or recorded during the PSG studies.
* Current Treatment for Sleep Disordered Breathing a) Subject currently uses devices prescribed for sleep disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, tongue displacement devices. b)Over-the-counter products such as chin straps, pillows, internal/external nasal dilators are acceptable provided usage is discontinued at least 28 days prior to Baseline.

Primary outcomes:
measure: Nasal Resistance in Sleeping State : Nasal Resistance Phase
timeFrame: upto 2 days
measure: Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
timeFrame: Day 1
measure: Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
timeFrame: Day 1
measure: Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
timeFrame: Day 1
Secondary outcomes:
measure: Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
timeFrame: Day 29
measure: Global Self Assessment Score : Active Phase
timeFrame: Day 29
measure: Total Epworth Sleepiness Scale Score (ESS) : Active Phase
timeFrame: Day 29
measure: Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
measure: Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
timeFrame: Day 1, Day 8, Day 29, Day 30 and Day 31
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wheatley JR, Amis TC, Lee SA, Ciesla R, Shanga G. Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Adv Ther. 2019 Jul;36(7):1657-1671. doi: 10.1007/s12325-019-00980-z. Epub 2019 May 22.