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Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

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ClinicalTrials.gov Identifier: NCT01122849
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : March 3, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Disorders Congestion, Nasal Device: Prototype Nasal Dilator Device: Marketed Nasal Strip Device: Placebo Nasal Strip Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Study Start Date : October 2009
Primary Completion Date : February 2010
Study Completion Date : February 2010
Arms and Interventions

Arm Intervention/treatment
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
Device: Placebo Nasal Strip
Placebo strip

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in responses to congestion and sleep questionnaire scores [ Time Frame: Baseline to day 14 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with leptorrhine noses
  • Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122849

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
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01122849     History of Changes
Other Study ID Numbers: B3570674
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

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

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