Spinal Cord InjuriesMELATETRANCT03167801
Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
An observational study of Spinal Cord Injuries, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2017to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal cord injury patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
APHP Hôpital Raymond poincaré
Garches, Île-de-France Region, 92380
About this study
To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.
Read the 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
- Keywords
- tetraplegia, spinal cord injury, melatonin, sleep quality, sleepiness
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Sleep Initiation and Maintenance Disorders, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 6-sulfatoxy-melatonin (U6SM)
Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours
Measured: 24 hours
Secondary outcomes (2)
Sleep quality
Pittsburgh Sleep Quality Index
Measured: 24 hours
Daytime sleepiness
Epworth Sleepiness Scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start11 Jul 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Antonia Quera-Salva, MD-PhD, Study director, APHP Hopital Raymond PoincareRaphaella Daville, MD, Principal investigator, APHP Hopital Raymond PoincareDjamel BENSMAIL, MD-PhD, Study chair, APHP Hopital Raymond Poincare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167801
- Sponsor's protocol ID
- 2016-A00605-46
- Acronym
- MELATETRA
- Status last verified
- Jul 2018
- First submitted
- 23 May 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT03167801
- Acronym / sponsor ID
- MELATETRA / 2016-A00605-46
- Conditions
- Spinal Cord Injuries
- Keywords
- tetraplegia, spinal cord injury, melatonin, sleep quality, sleepiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injury patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnant women
- Breast feeding women
- Refusal to participate at study
- Not covered by national health insurance scheme
- Patient unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary 6-sulfatoxy-melatonin (U6SM)
Time frame: 24 hours
Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours
2 secondary outcomes
Sleep quality
Time frame: 24 hours
Daytime sleepiness
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Antonia Quera-Salva, MD-PhD study director
APHP Hopital Raymond Poincare
Raphaella Daville, MD principal investigator
APHP Hopital Raymond Poincare
Djamel BENSMAIL, MD-PhD study chair
APHP Hopital Raymond Poincare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 6-sulfatoxy-melatonin (U6SM) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.