HypersomniaActisomNCT03459300
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)
An observational study of Hypersomnia, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersomnia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 17 Jan 2020
- 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: patients with a sleepiness evoking a primary hypersomnia
Who may be able to join
- Men or women aged > 18 years
- Patient with a sleepiness evoking a primary hypersomnia
- Epworth sleepiness scale > 10
- Information note signed
Who cannot join
- Patient with type 1 or 2 narcolepsy and/or known hypersomnia
- Frank cataplexy
- Not stable metabolic, neurological or psychiatric disease
- Patient treated by a medicine acting on the central nervous system
- Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
- Non affiliation to social security
- Pregnancy
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia
Read the detailed description
This is an observational study
Urine drug screening will also be performe
The suty includes four centers in France
The study duration is of one year
- Conditions
- Hypersomnia
- Keywords
- actimetry
- Medical subject headings
- Disorders of Excessive Somnolence
What is being measured
The primary outcome is the main question the study is designed to answer.
mean total sleep time
mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation
Measured: 7-14 days before hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Feb 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersomniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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, MDPhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459300
- Sponsor's protocol ID
- 16047
- Acronym
- Actisom
- Status last verified
- Jan 2021
- First submitted
- 2 Mar 2018
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia
- ClinicalTrials.gov ID
- NCT03459300
- Acronym / sponsor ID
- Actisom / 16047
- Conditions
- Hypersomnia
- Keywords
- actimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 8 Mar 2018 (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.
7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia
Detailed description
This is an observational study
Urine drug screening will also be performe
The suty includes four centers in France
The study duration is of one year
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a sleepiness evoking a primary hypersomnia
Key inclusion criteria (4 listed)
- Men or women aged > 18 years
- Patient with a sleepiness evoking a primary hypersomnia
- Epworth sleepiness scale > 10
- Information note signed
Key exclusion criteria (8 listed)
- Patient with type 1 or 2 narcolepsy and/or known hypersomnia
- Frank cataplexy
- Not stable metabolic, neurological or psychiatric disease
- Patient treated by a medicine acting on the central nervous system
- Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
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
mean total sleep time
Time frame: 7-14 days before hospitalisation
mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation
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 26 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Hypersomnia
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
Narcolepsy, Idiopathic Hypersomnia
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, MDPhD principal investigator
APHP
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 Hypersomnia, 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 4 inclusion and 8 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 26 Jan 2021. 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?
mean total sleep time (time frame: 7-14 days before hospitalisation). 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 26 Jan 2021.