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Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03167801
Acronym
MELATETRA
Enrollment
18
Registered
2017-05-30
Start date
2017-07-11
Completion date
2018-07-31
Last updated
2018-08-17

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

Conditions

Spinal Cord Injuries

Keywords

tetraplegia, spinal cord injury, melatonin, sleep quality, sleepiness

Brief summary

To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

Detailed description

Melatonin is a neurohormone secreted by the pineal gland and excreted by the urinary tract. It has a key role in the synchronisation of circadian rhythms including the sleep wake cycle, with a peak secretion around 03:00. The neural pathway controlling melatonin secretion is long and transits via the thoracic spine. The exact level is not known, but interruption of the connection in patients with lesions of the spinal cord is known to occur. Tetraplegic patients often complain of insomnia, daytime sleepiness and poor sleep quality but the contribution of melatonin levels to sleep quality has not been explored in large studies, although case reports have shown reduced or abolished melatonin secretion and altered melatonin secretion profiles with delayed peak secretion. Paraplegic patients report fewer sleep difficulties and little is known about melatonin secretion in this group. The investigators hypothesize that sleep abnormalities are related to abnormalities in melatonin secretion and that this is in turn related to the level of the spinal cord injury The study aims to explore the profiles of melatonin secretion in patients with spinal cord injuries and comparing melatonin profiles with a database of healthy volunteers. The investigators will further analyse the results looking at the severity of spinal cord injury using the Abbreviated Injury Scale (AIS) and the level of the injury. Outcome measures are melatonin secretion profile, sleep complaints measured using the Pittsburgh scale and daytime sleepiness measured using the Epworth sleep scale.

Interventions

None listed

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female ≥ 18 years * Spinal cord injury patient * All score AIS * With a chronic lesion (more than 6 months from initial injury) * Signed informed consent

Exclusion criteria

* Pregnant women * Breast feeding women * Refusal to participate at study * Not covered by national health insurance scheme * Patient unable to give informed consent * Transmeridian flight crossing more than 3 time zones in the month preceding the study * Recent treatment with melatonin (\< 1 month) or beta blocker

Design outcomes

Primary

MeasureTime frameDescription
Urinary 6-sulfatoxy-melatonin (U6SM)24 hoursUrinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours

Secondary

MeasureTime frameDescription
Sleep quality24 hoursPittsburgh Sleep Quality Index
Daytime sleepiness24 hoursEpworth Sleepiness Scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026