Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

NCT03167801 | Completed

• 1 other identifier: 2016-A00605-46
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries

Keywords

tetraplegia; spinal cord injury; melatonin; sleep quality; sleepiness

Outcome Measures

Primary Outcomes (1)

• Urinary 6-sulfatoxy-melatonin (U6SM)

  Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours

  24 hours

Secondary Outcomes (2)

• Sleep quality

  24 hours

• Daytime sleepiness

  24 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Spinal cord injury patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

APHP Hôpital Raymond poincaré

Garches, Île-de-France Region, 92380, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary samples

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Sleep Initiation and Maintenance Disorders; Sleepiness

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Maria Antonia Quera-Salva, MD-PhD

  APHP Hopital Raymond Poincare

  STUDY DIRECTOR

• Raphaella Daville, MD

  APHP Hopital Raymond Poincare

  PRINCIPAL INVESTIGATOR

• Djamel BENSMAIL, MD-PhD

  APHP Hopital Raymond Poincare

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: July 11, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)