Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000696998
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
7/07/2011
Date last updated
23/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Route of Breathing and Chinstrap Study
Scientific title
The influence of enforced nasal only breathing by use of chin strap and nasal decongestant on the severity of sleep disordered breathing in subjects referred to Westmead Sleep Service for investigation of Sleep Disordered breathing with moderate obstructive sleep apnoea who breathe oro-nasally during sleep.
Secondary ID [1] 262579 0
Nil.
Universal Trial Number (UTN)
U1111-1122-6689
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 268242 0
Obstructive Sleep Apnea 268243 0
Condition category
Condition code
Respiratory 268374 268374 0 0
Sleep apnoea
Respiratory 268375 268375 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A chin strap will be applied. Chin straps are commercially available devices used to prevent oral route breathing and mouth leak during CPAP (continuous positive airway pressure) therapy. A chin strap consists of a piece of soft flexible material designed to support mouth closure. An appropriately fitted Seatec (brand name) chin strap will be fitted. Nasal decongestant will also be used as an intervention to prevent oral route breathing. The chin strap will be applied for the duration of the sleep study. Nasal decongestant with oxymetazoline will be 2 sprays in each nostril prior to PSG (polysomnography i.e. sleep study) on the chin strap intervention night only. The two sleep studies i.e with chinstrap& decongestant spray and nil interventions will be seperated by no more than 1 week. PSG will be conducted with the same instrumentation on both study nights including calibrated sound recording and breathing route detection with thermistors. Anthropometric data including age, sex, height, weight, BMI, neck circumference will be collected. Questionnaires including sleep history, WSHQ, ESS, VAS for sleep quality, ease of nasal breathing will be conducted. Nasal Resistance with and without decongestant via posterior rhinomanometry prior to each PSG study. Standard Polysomnography using Compumedics Profusion 3 software. Calibrated sound recording for snoring with Rion SL Meters. Route of breathing using semi-calibrated nasal and oral thermistors. Subject perception questionnaires for sleep quality, dryness of mouth and ease of nasal breathing will be conducted at the end of the overnight study i.e morning. Randomisation will occur via reference to a statistical reference table prior to the first study night and after informed consent. Randomisation will mean the subject will be placed in the group that has no intervention on the first study night or the group that will have the chin strap & nasal spray intervention on the first night. The second study night will follow as chin strap & nasal spray if the first night was no intervention. The second study night will follow as no intervention if the first study night had chin strap & nasal spray.
Intervention code [1] 266910 0
Treatment: Devices
Intervention code [2] 266911 0
Prevention
Comparator / control treatment
Patients will have two sleep studies (PSG). The test night will have chin strap and nasal decongestion spray the control night will have no chin strap and no nasal decongestion spray.
Control group
Active

Outcomes
Primary outcome [1] 269143 0
The primary objective of this study is to determine the effect of preventing oral breathing (using a chin strap together with nasal decongestant to relieve nasal obstruction) on the severity of obstructive sleep apnea (OSA) determined by Apnea Hypopnea Index (AHI) and Respiratory Disturbance Index (RDI) in patients with mild to moderate OSA. Data analysis will include: nasal resistance measured at a flow of 0.4L/s both pre & post decongestant. Sleep studies (Polysomnographs i.e. PSG) will be scored for sleep staging and respiratory events using standard laboratory guidelines (AASM) by one scientist blinded to the study intervention. PSGs will be reported by physician blinded to the study intervention. Calculation of standard PSG parameters i.e Apnea Hypopnea Index (AHI), Respiratory Disturbance Index (RDI), Apnea Index (AI), RERAs (Respiratory Effort Related Arousals), Total Sleep Time (Total Sleep Time), Sleep efficiency, Wake and sleep onset (WASO, % sleep stage, snore index, snoring epochs, nasal and oro-nasal breathing epochs. Assessment for correlation between change in nasal only breathing epochs and change in SDB parameters.
Timepoint [1] 269143 0
At conclusion and on analysis of overnight sleep study.
Secondary outcome [1] 279018 0
Secondary end points are to determine the effect of preventing oral breathing (using a chin strap together with nasal decongestant to relieve nasal obstruction) on sleep disordered breathing (SDB) by the use of compumedics profusion 3 software and trained scientist for analysis and follow up sleep questionnaire.
Timepoint [1] 279018 0
At conclusion and on analysis of overnight sleep study.

Eligibility
Key inclusion criteria
1. Adult patients (>18 yrs) presenting to the Westmead Sleep Service for investigation of Sleep Disordered Breathing Sleep Disordered Breathing (SDB).
2. Baseline PSG demonstrating a Respiratory Disturbance Index between 10 and 30 events/hr.
3. Baseline Polysomnography (PSG) demonstrating oro-nasal breathing for > 50% total sleep
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Severe OSA with an RDI > 30 events/hr
2. Previous oro-nasal surgery
3. Prior motor vehicle accident due to sleepiness
4. Inability to breathe nasally-only
5. Significant co-morbid respiratory, neurological or cardiac disease
6. Diagnosis of another major sleep disorder
7. Acute upper respiratory tract infection at baseline
8. Severe nasal congestion caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator
9.Inability to refrain from use of alcohol on the study nights

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study is a prospective, randomised controlled design using a chin strap and nasal decongestant as the intervention to prevent oral route breathing. patients will be recruited prospectively from referrals from a University Hospital specifically Westmead Sleep Service for investigation of SDB. A sufficient number of subjects will be screened in order to enrol and complete 10 subjects as a pilot study. After giving written consent the subject will be randomised to receive either the first treatment night(prevention of oralnasal breathing by use of chin strap & nasal spray) or no treatment night then the alternate (either treatment or no treatment) on the second night.
Allocation is concealed central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software. After giving written consent the subject will be randomised to receive either the first treatment night(prevention of oralnasal breathing by use of chin strap & nasal spray) or no treatment night then the alternate (either treatment or no treatment) on the second night.Allocation is concealed central randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
1/06/2012
Date of last data collection
Anticipated
31/12/2019
Actual
1/06/2012
Sample size
Target
12
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4177 0
2120
Recruitment postcode(s) [2] 4178 0
2121
Recruitment postcode(s) [3] 4179 0
2123
Recruitment postcode(s) [4] 4180 0
2124
Recruitment postcode(s) [5] 4181 0
2125
Recruitment postcode(s) [6] 4182 0
2126
Recruitment postcode(s) [7] 4183 0
2127
Recruitment postcode(s) [8] 4184 0
2128
Recruitment postcode(s) [9] 4185 0
2129
Recruitment postcode(s) [10] 4186 0
2130
Recruitment postcode(s) [11] 4187 0
2131
Recruitment postcode(s) [12] 4188 0
2132
Recruitment postcode(s) [13] 4189 0
2133
Recruitment postcode(s) [14] 4190 0
2134
Recruitment postcode(s) [15] 4191 0
2135
Recruitment postcode(s) [16] 4192 0
2136
Recruitment postcode(s) [17] 4193 0
2137
Recruitment postcode(s) [18] 4194 0
2138
Recruitment postcode(s) [19] 4195 0
2140
Recruitment postcode(s) [20] 4196 0
2141
Recruitment postcode(s) [21] 4197 0
2142
Recruitment postcode(s) [22] 4198 0
2143
Recruitment postcode(s) [23] 4199 0
2144
Recruitment postcode(s) [24] 4200 0
2145
Recruitment postcode(s) [25] 4201 0
2146
Recruitment postcode(s) [26] 4202 0
2147
Recruitment postcode(s) [27] 4203 0
2148
Recruitment postcode(s) [28] 4204 0
2150
Recruitment postcode(s) [29] 4205 0
2151
Recruitment postcode(s) [30] 4206 0
2153
Recruitment postcode(s) [31] 4207 0
2154
Recruitment postcode(s) [32] 4208 0
2155
Recruitment postcode(s) [33] 4209 0
2156
Recruitment postcode(s) [34] 4210 0
2157
Recruitment postcode(s) [35] 4211 0
2158
Recruitment postcode(s) [36] 4212 0
2159
Recruitment postcode(s) [37] 4213 0
2160
Recruitment postcode(s) [38] 4214 0
2161
Recruitment postcode(s) [39] 4215 0
2162
Recruitment postcode(s) [40] 4216 0
2163
Recruitment postcode(s) [41] 4217 0
2164
Recruitment postcode(s) [42] 4218 0
2165

Funding & Sponsors
Funding source category [1] 267384 0
Self funded/Unfunded
Name [1] 267384 0
Ludwig Engel Centre for Respiratory Research
Country [1] 267384 0
Australia
Primary sponsor type
Individual
Name
Professor John Wheatley
Address
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country
Australia
Secondary sponsor category [1] 266448 0
None
Name [1] 266448 0
Address [1] 266448 0
Country [1] 266448 0
Other collaborator category [1] 252090 0
Individual
Name [1] 252090 0
Dr Vanitha Visvalingam
Address [1] 252090 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country [1] 252090 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269358 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 269358 0
Sydney West Area Health Service Human Research Ethics Committee
PO Box 533
WENTWORTHVILLE NSW 2145
Ethics committee country [1] 269358 0
Australia
Date submitted for ethics approval [1] 269358 0
13/07/2011
Approval date [1] 269358 0
08/09/2011
Ethics approval number [1] 269358 0

Summary
Brief summary
Mouth (oral) route breathing during sleep may be a risk factor for obstructive sleep apnoea (OSA) leading to increased disease severity related to a more collapsible upper airway. CPAP (continuous positive airway pressure) is the current gold standard treatment of choice for severe OSA for mild to moderate OSA CPAP is less convincing and often less well tolerated. Hence a range of alternative treatment options have been utilised with varying degres of success. Because of the lack of effective and iniversally acceptable therapies for OSA there remains a need to develop alternative approaches. One such approach maybe to prevent oral route breathing during sleep which maybe an important contributor to worsening uppder airway obstruction in subjects who breathing oronasally during sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32836 0
Prof John Wheatley
Address 32836 0
Westmead Hospital
Dept Respiratory and Sleep Medicine
Cnr Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 32836 0
Australia
Phone 32836 0
+61 2 8890 6797
Fax 32836 0
Email 32836 0
john.wheatley@sydney.edu.au
Contact person for public queries
Name 16083 0
Prof Professor John Wheatley
Address 16083 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 16083 0
Australia
Phone 16083 0
+61 2 9845 6797
Fax 16083 0
+61 2 9845 7286
Email 16083 0
john_wheatley@wmi.usyd.edu.au
Contact person for scientific queries
Name 7011 0
Prof Professor John Wheatley
Address 7011 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 7011 0
Australia
Phone 7011 0
+61 2 9845 6797
Fax 7011 0
+61 2 9845 7286
Email 7011 0
john_wheatley@wmi.usyd.edu.au

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Results publications and other study-related documents

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