Clinical trial NCT03167801: Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
Official title: Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: tetraplegia
spinal cord injury
melatonin
sleep quality
sleepiness
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spinal cord injury patients

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.

Eligibility 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

Primary outcomes:
measure: Urinary 6-sulfatoxy-melatonin (U6SM)
timeFrame: 24 hours
Secondary outcomes:
measure: Sleep quality
timeFrame: 24 hours
measure: Daytime sleepiness
timeFrame: 24 hours
Other outcomes:
Locations:
city: Garches
country: France
facility: APHP Hôpital Raymond poincaré
state: Ile De France
Study officials:
affiliation: APHP Hopital Raymond Poincare
name: Maria Antonia Quera-Salva, MD-PhD
role: STUDY_DIRECTOR
affiliation: APHP Hopital Raymond Poincare
name: Raphaella Daville, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP Hopital Raymond Poincare
name: Djamel BENSMAIL, MD-PhD
role: STUDY_CHAIR
References: