An Exploratory Study of a Nasal Dilator Strip

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01004471
First received: August 31, 2009
Last updated: October 11, 2012
Last verified: November 2011
  Purpose

The purpose of this exploratory study is to determine the effect of a prototype nasal dilator strip on nasal resistance during sleep in subjects who complain of chronic, nocturnal congestion and have trouble with their sleep.


Condition Intervention Phase
Sleep Disordered Breathing
Device: Prototype nasal dilator
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory Study of a Nasal Dilator Strip

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Nasal resistance measured by a modified method of posterior rhinomanometry [ Time Frame: night 1, night 2 ] [ Designated as safety issue: No ]
  • Apnea/hypopnea Index [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: baseline, 1 month ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Global Self Assessment [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prototype nasal dilator
External prototype nasal dilator strip. GSK prototype nasal dilator AB 2R11
Device: Prototype nasal dilator
External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004471

Locations
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01004471     History of Changes
Other Study ID Numbers: B3570581
Study First Received: August 31, 2009
Last Updated: October 11, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Adminstration

Keywords provided by GlaxoSmithKline:
Nasal dilator strip
Sleep disordered breathing

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 25, 2014