Clinical trial NCT01122849: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Official title: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disorders
Congestion, Nasal
Keywords: trouble with sleep
night time nasal congestion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Subjects with leptorrhine noses
* Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7
timeFrame: At Baseline and Day 7
measure: Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14
timeFrame: At Baseline and Day 14
measure: Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7
timeFrame: Day 7
measure: Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14
timeFrame: Day 14
measure: Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7
timeFrame: Day 7
measure: Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.
timeFrame: Day 14
measure: Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7
timeFrame: Day 7
measure: Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14
timeFrame: Day 14
measure: Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7
timeFrame: Day 7
measure: Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Summary for Other Questions of PIRS Questionnaire
timeFrame: At Day 7 and Day 14
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4)
timeFrame: on first night (Night 1) of each daily diary question
measure: Number of Participants Showing Improvement for VAS Scale Daily Diary Questions
timeFrame: on first night (Night 1) of each daily diary question
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research Inc
state: New Jersey
city: Bethlehem
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schenkel EJ, Ciesla R, Shanga GM. Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. Allergy Asthma Clin Immunol. 2018 Aug 27;14:34. doi: 10.1186/s13223-018-0258-5. eCollection 2018.