Last updated: 05/24/2019 10:00:10
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.n/a
GSK study ID
202203
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Exploratory Study of a Nasal Dilator Strip
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Nasal Resistance in Sleeping State : Nasal Resistance Phase
Timeframe: upto 2 days
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Timeframe: Day 1
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Timeframe: Day 1
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
Timeframe: Day 1
Secondary outcomes:
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
Timeframe: Day 29
Global Self Assessment Score : Active Phase
Timeframe: Day 29
Total Epworth Sleepiness Scale Score (ESS) : Active PhaseTotal Epworth Sleepiness Scale Score (ESS) : Active Phase
Timeframe: Day 29
Number of Snores per Hour : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
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
Percentage of participants with oro-nasal breathing route
Timeframe: At Baseline, Day 7, 28, 29 and 30
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
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
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
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
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
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
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
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
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
Apnea/hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31
Interventions:
Device: Prototype nasal dilator strip
Other: No strip
Enrollment:
91
Observational study model:
Not applicable
Primary completion date:
2010-10-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep disordered breathing, Congestion, Nasal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2009 to August 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-10-08
Actual study completion date
2010-10-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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