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

Study examining whether daily administration of 3mg melatonin alters subjective sleep experience and sleep architecture in people with complete quadriplegia

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000714280

Enrollment

Registered

2009-08-19

Start date

2009-08-25

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with complete quadriplegia commonly report sleep disturbances and have been found to lack melatonin production, a hormone that modulates our sleep cycle. It is unclear if their sleep problems are related to their lack of melatonin production. The aim of this study was to investigate whether nightly supplementation of 3mg melatonin would induce, shift the phase of and/or modify subjective sleep for people with complete quadriplegia. It is hypothesised that supplementation with melatonin will improve subjective sleep for people with complete quadriplegia along with their sleep phasing, quality of life and autonomic functioning.

Interventions

3 week within subject trial of daily evening administration of 3mg melatonin delivered orally. Randomised, double-blind, placebo controlled trial with two-week washout period between intervention and placebo treatments

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results