Trial Outcomes & Findings for Exploratory Subjective Sleep Study of a Prototype Nasal Dilator (NCT NCT01122849)

Participants were recruited at two centers in USA.

A total of 97 participants were screened for this study, out of which 61 participants were randomized to the study and 36 participants did not meet study criteria.

Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.)

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.)

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.)

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.)

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.