Melatonin Secretion and Sleep Quality i… | Clinical Trial

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Sleepiness Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP Hôpital Raymond poincaré

Garches, Île-de-France Region, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Urinary 6-sulfatoxy-melatonin (U6SM)

Time frame: 24 hours

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

Secondary outcomes

Sleep quality

Time frame: 24 hours

Pittsburgh Sleep Quality Index
Daytime sleepiness

Time frame: 24 hours

Epworth Sleepiness Scale

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: MELATETRA

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 30, 2017
Registry last updated: Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed