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.
Condition: Sleep Disordered Breathing; Congestion, Nasal
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Intervention: Prototype nasal dilator strip; No strip
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasal dilator strip; Sleep disordered breathing

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.
    

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.