An observational study in Sleep Fragmentation, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-12.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
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.
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.
309 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 51 observational studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who performed a spontaneous breathing polysomnography
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician
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 .
Time frame: One night
Ran from Nov 2014 to primary completion in Dec 2014, 1 month.
Of 23 observational studies under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 70. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer