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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03105297




Registration number
NCT03105297
Ethics application status
Date submitted
5/04/2017
Date registered
7/04/2017
Date last updated
7/04/2017

Titles & IDs
Public title
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.
Scientific title
An Exploratory Study of a Nasal Dilator Strip
Secondary ID [1] 0 0
202203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Prototype nasal dilator strip
Other interventions - No Strip

Experimental: Prototype nasal dilator (All participants) - This study was a baseline-controlled study. This study consisted of four phases, Screening phase, baseline phase, and 28 days Active phase followed by a two-night cross-over Nasal resistance phase. All the participants slept in the sleep laboratory at Day 1 (Night 1) in baseline phase. Participants wore the Nasal dilator strip over a 1 month in-home use period (Active phase) and returned for sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 29 and 30 (Night 30 and 31) separated by approximately two days where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip'.


Treatment: Devices: Prototype nasal dilator strip
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.

Other interventions: No Strip
All participants used the no strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nasal resistance in sleeping state - Nasal resistance of the participants was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the two nights of the nasal resistance phase.
Timepoint [1] 0 0
Up to 2 days
Primary outcome [2] 0 0
Area at Minimum cross sectional area 1 (MCA1) - Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
Timepoint [2] 0 0
At Day 1
Primary outcome [3] 0 0
Volume at Minimum cross sectional area 1 (MCA1) - Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
Timepoint [3] 0 0
At Day 1
Primary outcome [4] 0 0
Nasal resistance by posterior rhinomanometry - Nasal resistance was measured by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities. Posterior rhinomanometry was performed at baseline, Day1 (Visit 1) in baseline phase.
Timepoint [4] 0 0
At Day 1
Secondary outcome [1] 0 0
Total score of composite Functional Outcomes of Sleep Questionnaire (FOSQ) - The FOSQ was a 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life. The FOSQ was used in research and clinical practice to determine the extent to which intervention can improve the ability of participants with disorders of excessive sleepiness to conduct normal activities. The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score the questions of FOSQ which then grouped in above factors (were 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, moderate difficulty, 3= Yes, a little difficulty, and 4= No difficulty).
Timepoint [1] 0 0
At Day 29
Secondary outcome [2] 0 0
Global self assessment score - On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved.
Timepoint [2] 0 0
At Day 29
Secondary outcome [3] 0 0
Total Epworth Sleepiness Scale score (ESS) - Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing.
Timepoint [3] 0 0
At Day 29
Secondary outcome [4] 0 0
Number of snores per hour - The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [4] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [5] 0 0
Snoring percent of sleep time - The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [5] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [6] 0 0
Average snore sound intensity - The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [6] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [7] 0 0
Peak sore sound intensity - The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [7] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [8] 0 0
Percent of participants with nasal breathing route - The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase. Percentage of participants with breathing route observed as nasal was reported.
Timepoint [8] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [9] 0 0
Percentage of participants with oro-nasal breathing route - The Investigator or designee recorded the oro-nasal breathing route during the participant's domiciled sleep visits. Oro-nasal breathing route was observed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase. Percentage of participants with breathing route observed as oro-nasal was reported.
Timepoint [9] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [10] 0 0
Total sleep time (TST) - TST was measured by overnight polysomnography (PSG) using a computerized system. TST was measured at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [10] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [11] 0 0
Sleep efficiency (SE) - SE was measured by overnight PSG using a computerized system. SE was recorded at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [11] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [12] 0 0
Sleep onset latency (SOL) - SOL was measured by overnight PSG using a computerized system. SOL was recorded at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [12] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [13] 0 0
Arousal index (AI) - AI was measured by overnight PSG using a computerized system. AI recorded at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [13] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [14] 0 0
Sleep architecture (including stages N1, N2 and N3) - Sleep architecture was measured by overnight PSG using a computerized system. Sleep architecture included (% sleep stages including N1, N2, and N3). PSG was performed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [14] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [15] 0 0
Total Non-rapid eye movement (NREM) and Rapid eye movement (REM) sleep - Total NREM and REM sleep was measured by overnight PSG using a computerized system. PSG was performed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [15] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [16] 0 0
Respiratory effort related arousals (RERA) - RERA was measured by overnight PSG using a computerized system. PSG was performed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [16] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [17] 0 0
Lowest Arterial oxygen saturation (SAO2) in Non-rapid eye movement (NREM) and Rapid eye movement (REM) - SAO2 was measured overnight by pulse oximetry with a finger probe using a computerized system. Oximetry measurements were done at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [17] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [18] 0 0
Mean arterial oxygen saturation (SAO2) in sleep time - Mean SAO2 was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were done at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [18] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [19] 0 0
Arterial oxygen saturation (SAO2) average desaturation - SAO2 average desaturation was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were done at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [19] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [20] 0 0
Percent sleep time with arterial oxygen saturation (SAO2)>90% - Percent sleep time with SAO2 >90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were done at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [20] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [21] 0 0
Percent sleep time with arterial oxygen saturation (SAO2)<90% - Percent sleep time with SAO2<90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were done at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [21] 0 0
At Baseline, Day 7, 28, 29 and 30
Secondary outcome [22] 0 0
Apnea/hypopnea index (AHI) - AHI was measured overnight by PSG using a computerized system. PSG was performed at Day 1 (Visit 2) in Baseline phase, Day7, (Visit 3) and Day 28 (Visit 4) in Active phase, and at Day 29 (Visit 5) and Day 30 (Visit 6) in Nasal resistance phase.
Timepoint [22] 0 0
At Baseline, Day 7, 28, 29 and 30

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03105297
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications