Multiple SclerosisNCT00137904
Sleep Disorders in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with multiple sclerosis
- Expanded Disability Status Scale score < or = 5
- Fatigue (Modified Fatigue Impact Scale > 45), with a disease duration > 3 months
Who cannot join
- Depression
- Cognitive disorders
- EDSS > 5
- Epilepsia
- Obesity
- Drug inducing sleep disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière
Paris, 75013
Marie-Laure Welter, MD, 33-42161950, marie-laure.welter@psl.aphp.fr
Bruno Stankoff, MD, PhD
About this study
Official title: Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis
Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, sleep disorders
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Wake Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Other
- Enrolment
- 51 participants
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Stankoff, MD, PhD, Principal investigator, CIC-Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137904
- Sponsor's protocol ID
- RBM0242
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2005
- Last updated
- 9 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00137904
- Acronym / sponsor ID
- RBM0242
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, sleep disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- First posted
- 30 Aug 2005 (estimated)
- 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.
Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with multiple sclerosis
- Expanded Disability Status Scale score < or = 5
- Fatigue (Modified Fatigue Impact Scale > 45), with a disease duration > 3 months
Key exclusion criteria (6 listed)
- Depression
- Cognitive disorders
- EDSS > 5
- Epilepsia
- Obesity
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2006.
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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.
Bruno Stankoff, MD, PhD principal investigator
CIC-Pitié-Salpêtrière
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 Multiple Sclerosis, run by Groupe Hospitalier Pitie-Salpetriere 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Feb 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Stankoff, MD, PhD (33-142161950, bruno.stankoff@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Feb 2006.