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Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients (MELATETRA)

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ClinicalTrials.gov Identifier: NCT03167801
Recruitment Status : Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Spinal Cord Injuries

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.


Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
Anticipated Study Start Date : June 15, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
spinal cord injury
spinal cord injury all scores AIS
Healthy volunteers
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.


Outcome Measures

Primary Outcome Measures :
  1. Urinary 6-sulfatoxy-melatonin (U6SM) [ Time Frame: 24 hours ]
    Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 24 hours ]
    Pittsburgh Sleep Quality Index

  2. Daytime sleepiness [ Time Frame: 24 hours ]
    Epworth Sleepiness Scale


Biospecimen Retention:   Samples Without DNA
urinary samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Spinal cord injury patients
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Maria Antonia Quera Salva, MD-PhD 0033 147107900 ma.quera@aphp.fr
Contact: Erica VLACHOS, CRA 0033 147104472 erica.vlachos@aphp.fr

Locations
France
APHP Hôpital Raymond poincaré Not yet recruiting
Garches, Ile de France, France, 92380
Contact: Maria Antonia QUERA SALVA, MD-PhD    0033 147107940    ma.quera@aphp.fr   
Contact: Erica VLACHOS, CRA    0033 147104472    erica.vlachos@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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
More Information

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03167801     History of Changes
Other Study ID Numbers: 2016-A00605-46
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
tetraplegia
spinal cord injury
melatonin
sleep quality
sleepiness

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants