Sleep disruption in quadriplegia – A pilot study exploring whether 3mg melatonin induces sleep

Pilot study examining whether daily administration of 3mg melatonin alters sleep architecture in complete quadriplegia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000504314

Enrollment

Registered

2008-09-30

Start date

2008-09-01

Completion date

2009-03-01

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

This study will collect preliminary, pilot data regarding the feasibility and utility of supplemental melatonin to treat delayed sleep in quadriplegia

Interventions

Two week within subject (pre-post) trial of evening administration of 3mg melatonin delivered orally

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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.

Outcome results