An Exploratory Study of a Nasal Dilator Strip

Sleep Disordered Breathing Clinical Trial

Official title:

An Exploratory Study of a Nasal Dilator Strip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004471
• Other study ID #: B3570581
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2009
• Last updated: October 11, 2012
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Adminstration
• Study type: Interventional

Clinical Trial Summary

The purpose of this exploratory study is to determine the effect of a prototype nasal dilator strip on nasal resistance during sleep in subjects who complain of chronic, nocturnal congestion and have trouble with their sleep.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 <30 events/hour at the Baseline visit.

• Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping >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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep Disordered Breathing

Intervention

Device:
• Prototype nasal dilator
External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal resistance measured by a modified method of posterior rhinomanometry		night 1, night 2	No
Primary	Apnea/hypopnea Index		Baseline, 1 month	No
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ)		baseline, 1 month	No
Secondary	Adverse events		1 month	No
Secondary	Global Self Assessment		Baseline, 1 month	No