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Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01122849
First received: May 11, 2010
Last updated: January 24, 2013
Last verified: April 2012
History of Changes
  Purpose

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.


Condition Intervention Phase
Sleep Disorders
Congestion, Nasal
 Device: Prototype Nasal Dilator
Device: Marketed Nasal Strip
Device: Placebo Nasal Strip
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in responses to congestion and sleep questionnaire scores [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prototype Nasal Dilator
Prototype Nasal Dilator
 Device: Prototype Nasal Dilator
Prototype nasal dilator AB2R11
Active Comparator: Marketed Nasal Strip
Marketed Nasal Strip
 Device: Marketed Nasal Strip
Breathe Right Nasal Strip- Clear small/medium
Placebo Comparator: Placebo Nasal Strip
Placebo
 Device: Placebo Nasal Strip
Placebo strip

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with leptorrhine noses
  • Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122849

Locations
United States, New Jersey
TKL Research Inc
Paramus, New Jersey, United States, 07652
United States, Pennsylvania
Valley Clinical Research Center
Bethlehem, Pennsylvania, United States, 18020
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01122849     History of Changes
Other Study ID Numbers: B3570674
Study First Received: May 11, 2010
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
trouble with sleep
night time nasal congestion

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013