Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

NCT ID: NCT03167801

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-07-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

spinal cord injury

spinal cord injury all scores AIS

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Antonia Quera-Salva, MD-PhD

Role: STUDY_DIRECTOR

APHP Hopital Raymond Poincare

Raphaella Daville, MD

Role: PRINCIPAL_INVESTIGATOR

APHP Hopital Raymond Poincare

Djamel BENSMAIL, MD-PhD

Role: STUDY_CHAIR

APHP Hopital Raymond Poincare

Locations

APHP Hôpital Raymond poincaré

Garches, Île-de-France Region, France

Countries

France

Other Identifiers

2016-A00605-46

Identifier Type: -

Identifier Source: org_study_id