Last updated: 11/04/2018 05:40:57

Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

GSK study ID
B3570674
Clinicaltrials.gov ID
NCT01122849
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline in mean average score using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7

Timeframe: At Baseline and Day 7

Change from baseline in mean average score using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14

Timeframe: At Baseline and Day 14

Change from baseline in mean average score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for each domain (sleep, sleep time, symptoms on waking in the morning, and practical problems) on the) at Day 7

Timeframe: At Baseline and Day 7

Change from baseline in mean average score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for each domain (sleep, sleep time, symptoms on waking in the morning, and practical problems) on the) at Day 14

Timeframe: At Baseline and Day 14

Change from baseline in mean sum of 7 questions of Congestion Quantifier 7 questionnaire (CQ7) at Day 7

Timeframe: At Baseline and Day 7

Change from baseline in mean sum of 7 questions of Congestion Quantifier 7 questionnaire (CQ7) at Day 14

Timeframe: At Baseline and Day 14

Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7

Timeframe: Day 7

Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14

Timeframe: Day 14

Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7

Timeframe: Day 7

Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip removal in Morning on Day 14.

Timeframe: Day 14

Mean Score in response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7

Timeframe: Day 7

Mean score in response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14

Timeframe: Day 14

Mean score in response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7

Timeframe: Day 7

Mean score in response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14

Timeframe: Day 14

Secondary outcomes:

Summary for other questions of PIRS questionnaire

Timeframe: At Day 7 and Day 14

Summary of other daily diary VAS scale questions before and after strip application at bedtime

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of other daily diary VAS scale questions before and after strip removal in morning

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of other daily diary VAS scale questions before and after strip application at bedtime

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of other daily diary VAS scale questions before and after strip removal in morning.

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of daily diary questions before and after strip application at bedtime

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of Daily Dairy Questions before and after strip removal in morning

Timeframe: At Day 1, Day 2, day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13

Summary of Daily Diary questions at bed time (after strip application) and in morning (after strip removal).

Timeframe: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day13

Change from baseline in mean average score of NRQLQ for each domain (sleep, sleep time, symptoms on waking in the morning, and practical problems) on the) at Day 7 and Day 14 in participants with the risk of sleep apnea.

Timeframe: At Day 7 and at Day 14

Number of participants showing improvement for sleep problems and symptoms on waking in the morning domain of the NRQLQ

Timeframe: At Day 7 and Day 14

Number of participants showing improvement for daily diary questions (Q2 and Q4)

Timeframe: on first night (Night 1) of each daily diary question

Number of participants showing improvement for VAS scale daily diary questions

Timeframe: on first night (Night 1) of each daily diary question

Interventions:
  • Device: Prototype Nasal Dilator
  • Device: Marketed Nasal Strip
  • Device: Placebo Nasal Strip
    • Enrollment:
    61
    Primary completion date:
    2010-01-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Disorders, Congestion, Nasal
    Product
    Breathe Right
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to February 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Subjects with leptorrhine noses
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects with leptorrhine noses
    • Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    TKL Research Inc
    Paramus, NJ, United States, 07652
    Status
    Study Complete
    Contact us
    Location
    Valley Clinical Research Center
    Bethlehem, PA, United States, 18020
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-01-02
    Actual study completion date
    2010-04-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website