Sleep disruption in quadriplegia, its hormonal basis and a randomized controlled trial (RCT) of melatonin supplementatio

Completed

• Conditions: Chronic complete quadriplegia; Unrefreshed sleep; Neurological - Other neurological disorders; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000714280
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Complete (motor and sensory) quadriplegia (T1 or higher lesion), time since spinal cord injury is greater than one year (chronic)

Exclusion Criteria

Travel across three or more time zones within three weeks or during protocol, Pregnancy or breast feeding, Ongoing use of over-the-counter melatonin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved subjective sleep experience measured by a daily sleep diary and the Basic Nordic Sleepiness Questionnaire and the Sleep Disturbance Severity Scale[Baseline and 3, 5, and 8 weeks after randomisation]

Secondary Outcome Measures

Name	Time	Method
Improved phasing of sleep as measured by polysomnography[Baseline and 3, 5, and 8 weeks after randomisation];Improved Quality of life as measured by the Assessment of Quality of Life Questionnaire, the Hospital Anxiety Depression Scale and the Profile of Moods States[Baseline and 3, 5, and 8 weeks after randomisation];Improved autonomic functioning as assessed by a portable blood pressure and heart rate monitor, Orthostatic Hypotension Questionnaire and urine catecholamine and electrolyte levels[Baseline and 3, 5, and 8 weeks after randomisation]