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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 : Recruiting
First Posted : May 30, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

May 23, 2017
May 30, 2017
January 25, 2018
July 11, 2017
January 30, 2018   (Final data collection date for primary outcome measure)
Urinary 6-sulfatoxy-melatonin (U6SM) [ Time Frame: 24 hours ]
Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours
Same as current
Complete list of historical versions of study NCT03167801 on ClinicalTrials.gov Archive Site
  • Sleep quality [ Time Frame: 24 hours ]
    Pittsburgh Sleep Quality Index
  • Daytime sleepiness [ Time Frame: 24 hours ]
    Epworth Sleepiness Scale
  • Sleep quality [ Time Frame: during inclusion ]
    Pittsburgh Sleep Quality Index
  • Daytime sleepiness [ Time Frame: during inclusion ]
    Epworth Sleepiness Scale
Not Provided
Not Provided
 
Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

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.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
urinary samples
Probability Sample
Spinal cord injury patients
Spinal Cord Injuries
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
January 30, 2018
January 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Maria Antonia Quera Salva, MD-PhD 0033 147107900 ma.quera@aphp.fr
Contact: Erica VLACHOS, CRA 0033 147104472 erica.vlachos@aphp.fr
France
 
 
NCT03167801
2016-A00605-46
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
Not Provided
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
Centre d'Investigation Clinique et Technologique 805
June 2017