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

Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

GSK study ID

B3570674

Clinicaltrials.gov ID

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Completed

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

Observational study model:

Not applicable

Primary completion date:

2010-01-02

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

Trial location(s)

Location

Status

Contact us

Location

TKL Research Inc

Paramus, NJ, United States, 07652

Status

Study Complete

Location

Valley Clinical Research Center

Bethlehem, PA, United States, 18020

Status

Study Complete

Study documents

No study documents available.

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

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

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