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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
26/07/2019

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
Congestion, Nasal 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: All participants (Baseline phase) - All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1.

Experimental: All Participants (Active Phase) - All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment

Experimental: All Participants (Nasal Resistance Phase) - The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule


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
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 Phase
Timepoint [1] 0 0
upto 2 days
Primary outcome [2] 0 0
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
Timepoint [4] 0 0
Day 1
Secondary outcome [1] 0 0
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
Timepoint [1] 0 0
Day 29
Secondary outcome [2] 0 0
Global Self Assessment Score : Active Phase
Timepoint [2] 0 0
Day 29
Secondary outcome [3] 0 0
Total Epworth Sleepiness Scale Score (ESS) : Active Phase
Timepoint [3] 0 0
Day 29
Secondary outcome [4] 0 0
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Timepoint [4] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [5] 0 0
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Timepoint [5] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [6] 0 0
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Timepoint [6] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [7] 0 0
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Timepoint [7] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [8] 0 0
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Timepoint [8] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [9] 0 0
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Timepoint [9] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [10] 0 0
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Timepoint [10] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [11] 0 0
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Timepoint [11] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [12] 0 0
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Timepoint [12] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [13] 0 0
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Timepoint [13] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [14] 0 0
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
Timepoint [14] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [15] 0 0
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
Timepoint [15] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [16] 0 0
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Timepoint [16] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [18] 0 0
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Timepoint [18] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [19] 0 0
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Timepoint [19] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [20] 0 0
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Timepoint [20] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [21] 0 0
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Timepoint [21] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31
Secondary outcome [22] 0 0
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Timepoint [22] 0 0
Day 1, Day 8, Day 29, Day 30 and Day 31

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
Sex
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
Crossover
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
25/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2010
Sample size
Target
Accrual to date
Final
91
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

For IPD and results data, please see https://clinicaltrials.gov/show/NCT03105297