Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

NCT01122849 | Completed Phase 2 Results

• 1 other identifier: B3570674
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Disorders; Congestion, Nasal

Keywords

trouble with sleep; night time nasal congestion

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (12)

• Summary for Other Questions of PIRS Questionnaire

  At Day 7 and Day 14

• Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime

  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

  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

  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.

  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

Study Arms (3)

Prototype Nasal Dilator

EXPERIMENTAL

Prototype Nasal Dilator

Device: Prototype Nasal Dilator

Marketed Nasal Strip

ACTIVE COMPARATOR

Marketed Nasal Strip

Device: Marketed Nasal Strip

Placebo Nasal Strip

PLACEBO COMPARATOR

Placebo

Device: Placebo Nasal Strip

Interventions

Prototype Nasal Dilator DEVICE

Prototype nasal dilator AB2R11

Prototype Nasal Dilator

Marketed Nasal Strip DEVICE

Breathe Right Nasal Strip- Clear small/medium

Marketed Nasal Strip

Placebo Nasal Strip DEVICE

Placebo strip

Placebo Nasal Strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

TKL Research Inc

Paramus, New Jersey, 07652, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Related Publications (1)

• 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.

  PMID: 30154874 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Nasal Obstruction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-01

Locations

US (2)