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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12608000504314 |
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Date of registration:
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30/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sleep disruption in quadriplegia – A pilot study exploring whether 3mg melatonin induces sleep
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Scientific title:
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Pilot study examining whether daily administration of 3mg melatonin alters sleep architecture in complete quadriplegia |
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Date of first enrolment:
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01/09/2008 |
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Target sample size:
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5 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12608000504314.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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A/Prof David Berlowitz
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Address:
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Institute for Breathing and Sleep
Bowen Centre. Austin Health
Studley Rd. Heidelberg Vic 3084
Australia |
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Telephone:
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0394963688 |
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Email:
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david.berlowitz@austin.org.au |
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Affiliation:
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Name:
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A/Prof David Berlowitz
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Address:
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Institute for Breathing and Sleep
Bowen Centre. Austin Health
Studley Rd. Heidelberg Vic 3084
Australia |
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Telephone:
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0394963688 |
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Email:
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david.berlowitz@austin.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Complete (motor and sensory) quadriplegia (T1 or higher lesion)
Exclusion criteria: Major psychological or psychiatric disturbances, Neurological damage other than spinal cord injury, Other significant co-morbidity, Beta blockers.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Respiratory - Other respiratory disorders / diseases
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Unrefreshing sleep;
Unrefreshing sleep
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Intervention(s)
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Two week within subject (pre-post) trial of evening administration of 3mg melatonin delivered orally
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Primary Outcome(s)
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Rapid Eye Movement (REM) sleep latency measured using portable polysomnography[Baseline and two weeks]
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Secondary Outcome(s)
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Sleepiness (Karolinska Sleepiness Scale)[Baseline and two weeks]
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Salivary melatonin concentrations[Baseline and two weeks. Measures made immediately prior to melatonin administration, at participants usual sleep time (2 hours later) and upon awakening the next morning]
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Source(s) of Monetary Support
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Institute for breathing and sleep
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Ethics review
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Status: Approved
Approval date:
Contact:
Austin Hospital Human Research Ethics Unit
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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