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Phase 2 N=91 Randomized Basic Science

To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.

Sleep Disordered Breathing · Congestion, Nasal

Enrolled (actual)
91
Serious AEs
0.4%
Results posted
Jul 2019
Primary outcome: Primary: Nasal Resistance in Sleeping State : Nasal Resistance Phase — 2.658; 2.202 Centimeter (cm) H2O/liter/sec — p=0.0147

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Prototype nasal dilator strip (Device); No strip (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Aug 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Nasal Resistance in Sleeping State : Nasal Resistance Phase
2.658; 2.202 0.0147 sig
PRIMARY
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
1.949; 2.535 <0.0001 sig
PRIMARY
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
4.145; 5.043 <0.0001 sig
PRIMARY
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
4.468; 3.251 0.0073 sig
SECONDARY
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
17.55
SECONDARY
Global Self Assessment Score : Active Phase
1.4; 0.6; 0.8; 0.7; 0.7; 0.3
SECONDARY
Total Epworth Sleepiness Scale Score (ESS) : Active Phase
7.410
SECONDARY
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
308.18; 299.58; 330.30; 317.76; 324.92
SECONDARY
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
40.33; 38.70; 42.41; 42.11; 43.22
SECONDARY
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
40.67; 41.85; 44.14; 43.10; 43.89
SECONDARY
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
67.84; 66.44; 69.87; 69.48; 70.28
SECONDARY
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
26.38; 27.78; 31.25; 44.71; 48.40
SECONDARY
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
70.92; 70.26; 64.44; 51.04; 47.60
SECONDARY
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
369.54; 371.97; 366.26; 317.98; 304.65
SECONDARY
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
80.50; 81.66; 82.25; 75.56; 73.63
SECONDARY
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
13.86; 14.92; 9.69; 14.29; 18.45
SECONDARY
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
25.12; 25.24; 25.97; 35.33; 38.33
SECONDARY
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
8.30; 7.58; 8.46; 7.65; 8.82; 47.93
SECONDARY
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
296.30; 294.17; 289.48; 264.82; 249.63; 73.10
SECONDARY
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
14.62; 16.80; 16.30; 20.65; 23.88
SECONDARY
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
91.33; 91.17; 91.34; 92.30; 92.42; 91.01
SECONDARY
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
95.70; 95.70; 95.64; 96.69; 96.71
SECONDARY
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
4.41; 4.68; 3.49; 2.90; 3.33
SECONDARY
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
98.59; 97.38; 98.21; 98.41; 99.18
SECONDARY
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
0.66; 1.29; 0.56; 0.49; 0.12
SECONDARY
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
4.08; 4.26; 5.07; 6.57; 7.11

Summary

To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.

Eligibility Criteria

Inclusion Criteria

  • Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
  • Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
  • Sleep: Reports trouble with sleep

Exclusion Criteria

  • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
  • Subject has a chronic skin condition or eczema on the face or nose.
  • Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
  • Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score 2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
  • Subject has a non-typical sleep schedule (e.g. shift-work).
  • Subject plans travel involving time-zone changes during the study period.
  • Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.
  • Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.
  • Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.
  • Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
  • Subject has a positive drug of abuse screening result.
  • Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.
  • Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.
  • Subject is unwilling to be videotaped or recorded during the PSG studies.
  • Current Treatment for Sleep Disordered Breathing a) Subject currently uses devices prescribed for sleep disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, tongue displacement devices. b)Over-the-counter products such as chin straps, pillows, internal/external nasal dilators are acceptable provided usage is discontinued at least 28 days prior to Baseline.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03105297). 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.

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