Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI) (SDI)
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|ClinicalTrials.gov Identifier: NCT02843737|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment|
|Sleep Fragmentation||Other: 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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)|
|Actual Study Start Date :||November 21, 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 16, 2017|
- Other: Polysomnography under spontaneous breathing
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 [ Time Frame: One night ]In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843737
|Dijon, France, 21079|
|Poitiers, France, 86021|
|Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)|
|Toulon, France, 83056|
|Principal Investigator:||Daniel D'AMORE, MD||Centre Hospitalier Intercommunal Toulon La Seyne sur mer|