Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

Study Overview
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Brief Summary
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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.

Official Title
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Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

Conditions
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Sleep Disorders, Congestion, Nasal

Intervention / Treatment
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* Device: Prototype Nasal Dilator
* Device: Marketed Nasal Strip
* Device: Placebo Nasal Strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with leptorrhine noses Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype Nasal Dilator<br>Prototype Nasal Dilator | Device: Prototype Nasal Dilator<br>* Prototype nasal dilator AB2R11<br>|
| Active Comparator: Marketed Nasal Strip<br>Marketed Nasal Strip | Device: Marketed Nasal Strip<br>* Breathe Right Nasal Strip- Clear small/medium<br>|
| Placebo Comparator: Placebo Nasal Strip<br>Placebo | Device: Placebo Nasal Strip<br>* Placebo strip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7 | The PIRS questionnaire had 3 sections (Section A [Q1 to Q12], Section B [Q13 to 16] and Section C [Q17 to Q20]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Q15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality. | 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 | Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality. | 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 | Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms. | 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 | Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms. | At Baseline and Day 14 | 
| Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7 | Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lower CQ7 scores reflect better nasal patency. | At Baseline and Day 7 | 
| Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14 | Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lowe CQ7 scores reflect better nasal patency. | 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 | Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily. | Day 7 | 
| Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14 | Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily. | Day 14 | 
| Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7 | Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily. | Day 7 | 
| Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14. | Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy | Day 14 | 
| Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7 | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for Q4.) | Day 7 | 
| Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14 | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2, the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for question 4.) | Day 14 | 
| Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7 | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better. (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.) | Day 7 | 
| Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14 | Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.) | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary for Other Questions of PIRS Questionnaire | The following questions were asked from Section A (Q1 to Q12; 2 Not getting enough sleep, 4 Poor alertness during the daytime, 5 Difficulty keeping your thoughts focused, 6 Others noticing you appeared tired or fatigued, 7 too many difficulties to overcome, 8 Bad moods because you had poor sleep, 9 Lack of energy because of poor sleep, 10 Poor sleep that interferes with your relationships, 11 Being unable to sleep, 12 Being able to do only enough to get by, Section B (Q13 to Q16; 13 From the time you tried to go to sleep, How long did it take to fall asleep on most nights, 14 If you woke during the night, how long did it take to fall back to sleep on most nights,15 Not counting times when you were awake in bed, how many hours of actual sleep did you get during the worst night, 16 On how many days did you have trouble coping because of poor sleep and Section C (Q17 to Q20;, 19 The regularity of your sleep, 20 The soundness of your sleep) | At Day 7 and Day 14 | 
| Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime | Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily. | 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 | Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily. | 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 | Participants were asked how open their nose feels before and after strip application at bedtime. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily. | 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. | Participants were asked how open their nose feels before and after strip removal in morning. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily. | 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 | Participants were asked how stuffed their nose felt before and after strip application at bed time. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily. | 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 | Participants were asked how stuffed their nose felt before and after strip removal in morning. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily. | 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). | Participants were asked how breathing felt after nasal strip was applied at bed time and removed in morning. The participants scored their responses on the scale of -5 to 5 where -5 = much worse, 0 = same and 5= much better. These responses were recorded daily. | 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. | Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms. | 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 | Participants scored all two domains of NRQLQ using same 7 points scale: 0=Not troubled, 1=Hardly troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Domains were Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score), and Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up); Lower scores indicate improvement in the rhinitis symptoms. | At Day 7 and Day 14 | 
| Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4) | Participants were asked Q2 (How stuffed does your nose feel at this time?) and Q4 (How Breathing felt after the nasal strip was applied) of daily diary questions. Q2 was scored on 4 point scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms and Q4 on 11 point scale where -5=much worse, 0=same, 5=much better. | on first night (Night 1) of each daily diary question | 
| Number of Participants Showing Improvement for VAS Scale Daily Diary Questions | Participants were asked following daily diary VAS scale questions a) How easy it was to breathe through your nose and b) How open their nose feels at this time. Both of these questions were scored using 100 mm VAS scale where, 0=extremely difficult, 100=extremely easy. | on first night (Night 1) of each daily diary question | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trouble with sleep, night time nasal congestion