Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients (MELATETRA)
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|ClinicalTrials.gov Identifier: NCT03167801|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : January 25, 2018
|Condition or disease|
|Spinal Cord Injuries|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients|
|Actual Study Start Date :||July 11, 2017|
|Estimated Primary Completion Date :||January 30, 2018|
|Estimated Study Completion Date :||January 30, 2018|
spinal cord injury
spinal cord injury all scores AIS
Healthy volunteers for whom melatonin profiles have been taken and stored in the Lyon endocrinology laboratory's database. No healthy volunteers will be directly recruited for the study.
- Urinary 6-sulfatoxy-melatonin (U6SM) [ Time Frame: 24 hours ]Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours
- Sleep quality [ Time Frame: 24 hours ]Pittsburgh Sleep Quality Index
- Daytime sleepiness [ Time Frame: 24 hours ]Epworth Sleepiness Scale
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167801
|Contact: Maria Antonia Quera Salva, MD-PhD||0033 firstname.lastname@example.org|
|Contact: Erica VLACHOS, CRA||0033 email@example.com|
|APHP Hôpital Raymond poincaré||Recruiting|
|Garches, Ile De France, France, 92380|
|Contact: Maria Antonia QUERA SALVA, MD-PhD 0033 147107940 firstname.lastname@example.org|
|Contact: Erica VLACHOS, CRA 0033 147104472 email@example.com|
|Study Director:||Maria Antonia Quera-Salva, MD-PhD||APHP Hopital Raymond Poincare|
|Principal Investigator:||Raphaella Daville, MD||APHP Hopital Raymond Poincare|
|Study Chair:||Djamel BENSMAIL, MD-PhD||APHP Hopital Raymond Poincare|