Phase 2
N=61
Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
Sleep Disorders · Congestion, Nasal
Bottom Line
View on ClinicalTrials.gov: NCT01122849 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7 — -0.911; -0.694; -1.032; -1.004 Score on a scale — p=0.5456
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prototype Nasal Dilator (Device); Marketed Nasal Strip (Device); Placebo Nasal Strip (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7 |
-0.911; -0.694; -1.032; -1.004; -0.708; -0.947 | 0.5456 |
| PRIMARY Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14 |
-1.047; -0.844; -1.157; -1.306; -0.917; -1.104 | 0.5958 |
| PRIMARY 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 |
-7.398; -4.194; -6.563; -7.494; -5.638; -8.212 | 0.5462 |
| PRIMARY 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 |
-7.624; -5.738; -7.051; -8.746; -7.051; -6.768 | 0.6804 |
| PRIMARY Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7 |
-6.845; -5.137; -8.184 | 0.4258 |
| PRIMARY Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14 |
-8.035; -5.102; -6.917 | 0.4820 |
| PRIMARY Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7 |
32.10; 36.37; 40.53; 58.95; 47.42; 61.11 | 0.5278 |
| PRIMARY Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14 |
39.90; 43.21; 45.89; 68.70; 51.05; 67.56 | 0.4483 |
| PRIMARY Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7 |
60.15; 46.95; 62.63; 43.10; 44.74; 60.00 | 0.0029 sig |
| PRIMARY Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14. |
67.80; 48.95; 70.61; 51.35; 45.26; 61.11 | 0.1764 |
| PRIMARY Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7 |
1.75; 1.70; 1.63; 1.00; 1.55; 1.16 | 0.1345 |
| PRIMARY Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14 |
1.40; 1.58; 1.61; 0.85; 1.35; 1.06 | 0.8063 |
| PRIMARY Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7 |
1.00; 1.60; 1.00; 1.35; 1.75; 1.11 | 0.1991 |
| PRIMARY Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14 |
0.95; 1.40; 0.89; 1.30; 1.45; 1.17 | 0.5741 |
| SECONDARY Summary for Other Questions of PIRS Questionnaire |
1.20; 1.40; 1.37; 0.90; 1.20; 0.95 | — |
| SECONDARY Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime |
27.90; 37.74; 35.89; 61.45; 45.84; 57.68 | — |
| SECONDARY Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning |
54.60; 45.11; 60.44; 44.75; 41.47; 51.44 | — |
| SECONDARY Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime |
27.90; 37.74; 35.89; 61.45; 45.84; 57.68 | — |
| SECONDARY Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning. |
53.95; 45.37; 60.22; 44.70; 42.53; 51.56 | — |
| SECONDARY Summary of Daily Diary Questions Before and After Strip Application at Bedtime |
1.95; 2.00; 1.79; 1.10; 1.80; 1.26 | — |
| SECONDARY Summary of Daily Dairy Questions Before and After Strip Removal in Morning |
1.15; 1.55; 1.22; 1.35; 1.65; 1.33 | — |
| SECONDARY Summary of Daily Diary Questions at Bed Time (After Strip Application) and in Morning (After Strip Removal). |
2.45; 1.20; 1.42; -0.30; 0.25; 0.50 | — |
| SECONDARY 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. |
7.62; 11.58; 6.09; 6.92; 9.75; 4.91 | — |
| SECONDARY Number of Participants Showing Improvement for Sleep Problems and Symptoms on Waking in the Morning Domain of the NRQLQ |
14; 5; 11; 12; 10; 13 | — |
| SECONDARY Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4) |
13; 3; 10; 18; 11; 12 | — |
| SECONDARY Number of Participants Showing Improvement for VAS Scale Daily Diary Questions |
20; 11; 15; 19; 13; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT01122849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.