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Trial registered on ANZCTR


Registration number
ACTRN12615000229572
Ethics application status
Approved
Date submitted
12/02/2015
Date registered
12/03/2015
Date last updated
26/10/2018
Date data sharing statement initially provided
26/10/2018
Date results information initially provided
26/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of nasal decongestion on obstructive sleep apnoea severity in people with tetraplegia
Scientific title
A proof-of-concept study of the effect of nasal phenyepherine versus placebo on the apnoea hypopnoea index in participants with tetraplegia and sleep apnoea
Secondary ID [1] 286070 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 294064 0
Tetraplegia 294436 0
Condition category
Condition code
Respiratory 294363 294363 0 0
Sleep apnoea
Neurological 294364 294364 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose only of 0.5ml of 0.5% nasal phenyepherine spray delivered immediately prior to sleep.
Intervention order will be randomised and there will be a one-week washout period between treatments.
Intervention code [1] 291058 0
Treatment: Drugs
Comparator / control treatment
Single dose only of 0.5ml of normal saline nasal spray delivered immediately prior to sleep.
Control group
Active

Outcomes
Primary outcome [1] 294161 0
The difference between the two treatment arms in the apnoea hypopnoea index (events per hour) obtained during the first 50% of the study nights.
Timepoint [1] 294161 0
The first 50% of the total sleep time on each of the two sleep studies
Secondary outcome [1] 312652 0
The difference between the two treatment arms in the total apnoea hypopnoea index (events per hour) obtained during the study nights.

Timepoint [1] 312652 0
The total sleep time on each of the two sleep studies

Secondary outcome [2] 312774 0
Difference in nasal resistance as assessed using nasal rhinometry

Timepoint [2] 312774 0
Immediately before and after instillation of either treatment A or B at the beginning of each study night.

Secondary outcome [3] 312775 0
Difference in subjective rating of nasal congestion (Modified Borg Congestion scale & Nasal Congestion Questionnaire)
Timepoint [3] 312775 0
Immediately before and after instillation of either treatment A or B at the beginning of each study night (Modified Borg Congestion scale) and in the evening before each of the sleep studies (Nasal Congestion Questionnaire).
Secondary outcome [4] 312776 0
Difference in the route of breathing (proportion of the respiratory events that are identified as being through the nasal versus oral route as assessed using nasal pressure and thermistor)
Timepoint [4] 312776 0
The total sleep time on each of the two sleep studies

Secondary outcome [5] 312777 0
Difference in sleep quality as defined by the Arousal Index per hour of sleep in the first 50% of the study nights.
Timepoint [5] 312777 0
The first 50% of the total sleep time on each of the two sleep studies
Secondary outcome [6] 312928 0
The difference between the two treatment arms in the 4% desaturation rate as assessed using pulse oximetry (events per hour) obtained during the entire study nights.
Timepoint [6] 312928 0
The total sleep time on each of the two sleep studies

Eligibility
Key inclusion criteria
Tetraplegia
obstructive sleep apnoea as defined as having an apnoea hypopnoea index of greater than 10 events per hour

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurologic condition other than tetraplegia
Uncontrolled hypertension
Significant head injury
Ongoing hypercapnic ventilatory failure
Allergy to phenylephrine or lignocaine
Inability to provide informed consent
Fixed nasal obstruction (i.e. nasal fracture or deviated septum)
Use of other medication that could influence nasal patency
Use of bronchodilators or corticosteroid inhalers

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)
Sequential enrollment of eligible participants identified from clinical unit records.
Central, independent online treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized order drug administration. Sequence generated on randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 290657 0
Government body
Name [1] 290657 0
National Health and Medical Research Council
Address [1] 290657 0
GPO Box 1421
Canberra ACT 2601
Country [1] 290657 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
155 Studley Rd. Heidelberg 3084 Vic
Country
Australia
Secondary sponsor category [1] 289350 0
Charities/Societies/Foundations
Name [1] 289350 0
Institute for Breathing and Sleep
Address [1] 289350 0
Bowen Centre. Austin Health, 155 Studley Rd. Heidelberg 3084 Vic
Country [1] 289350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292288 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 292288 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
RANDWICK NSW 2031
Ethics committee country [1] 292288 0
Australia
Date submitted for ethics approval [1] 292288 0
Approval date [1] 292288 0
24/06/2014
Ethics approval number [1] 292288 0
141032 (HREC/14|POWH/í33)

Summary
Brief summary
The study will trial a common nasal decongestant to determine its effect on OSA severity in people with tetraplegia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54478 0
Dr David Berlowitz
Address 54478 0
Institute for Breathing and Sleep
Bowen Centre
155 Studley Rd
Austin Health
Heidelberg 3084 Vic
Country 54478 0
Australia
Phone 54478 0
+61394963877
Fax 54478 0
Email 54478 0
david.berlowitz@austin.org.au
Contact person for public queries
Name 54479 0
Dr David Berlowitz
Address 54479 0
Institute for Breathing and Sleep
Bowen Centre
155 Studley Rd
Austin Health
Heidelberg 3084 Vic
Country 54479 0
Australia
Phone 54479 0
+61394963877
Fax 54479 0
Email 54479 0
david.berlowitz@austin.org.au
Contact person for scientific queries
Name 54480 0
Dr David Berlowitz
Address 54480 0
Institute for Breathing and Sleep
Bowen Centre
155 Studley Rd
Austin Health
Heidelberg 3084 Vic
Country 54480 0
Australia
Phone 54480 0
+61394963877
Fax 54480 0
Email 54480 0
david.berlowitz@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval obtained to support such a request
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary