Sleep FragmentationSDINCT02843737
Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)
An observational study of Sleep Fragmentation, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in France.
Trial summary
The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Fragmentation
- What is being tested?
- Polysomnography under spontaneous breathing
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Nov 2014to 16 Mar 2017
- 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 who performed a spontaneous breathing polysomnography
Who may be able to join
- Spontaneous polysomnography
Who cannot join
- Insomnia
- Patients with psychoactive drug having an important effect on sleep
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Dijon
Dijon, 21079
CHU Poitiers
Poitiers, 86021
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)
Toulon, 83056
About this study
The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.
Read the detailed description
Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI).
In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented.
To validate our SDI it is necessary to compare this diagnosis tool to a "gold standard" based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.
- Conditions
- Sleep Fragmentation
- Being tested
- Polysomnography under spontaneous breathing
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography under spontaneous breathingOther
Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing
In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start21 Nov 2014
- Primary completionDec 2014
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep FragmentationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toulon, bio N com Association
- Responsible party
- Sponsor
- Investigators
- Daniel D'AMORE, MD, Principal investigator, Centre Hospitalier Intercommunal Toulon La Seyne sur mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843737
- Sponsor's protocol ID
- CH-2014-02 / IDS 2
- Acronym
- SDI
- Status last verified
- May 2017
- First submitted
- 20 Jul 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)
- ClinicalTrials.gov ID
- NCT02843737
- Acronym / sponsor ID
- SDI / CH-2014-02 / IDS 2
- Conditions
- Sleep Fragmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- University of Toulon, bio N com Association
- Study start
- 21 Nov 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 26 Jul 2016 (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.
The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.
Detailed description
Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI).
In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented.
To validate our SDI it is necessary to compare this diagnosis tool to a "gold standard" based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.
Study design
- Observational model
- Case only
- 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 who performed a spontaneous breathing polysomnography
Key inclusion criteria (1 listed)
- Spontaneous polysomnography
Key exclusion criteria (2 listed)
- Insomnia
- Patients with psychoactive drug having an important effect on sleep
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysomnography under spontaneous breathingPatient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician | Other | – |
Primary outcome
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing
Time frame: One night
In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .
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 12 May 2017.
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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.
Daniel D'AMORE, MD principal investigator
Centre Hospitalier Intercommunal Toulon La Seyne sur mer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Fragmentation, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites 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 1 inclusion and 2 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing (time frame: One night). 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 12 May 2017.