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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
Sponsor:
Collaborators:
Toulon University
bio N com Association
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Brief 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.

Condition or disease Intervention/treatment
Sleep Fragmentation Other: 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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • Other: Polysomnography under spontaneous breathing
    Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician


Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who performed a spontaneous breathing polysomnography
Criteria

Inclusion Criteria:

  • Spontaneous polysomnography

Exclusion Criteria:

  • Insomnia
  • Patients with psychoactive drug having an important effect on sleep

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843737


Locations
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France
CHU Dijon
Dijon, France, 21079
CHU Poitiers
Poitiers, France, 86021
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)
Toulon, France, 83056
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Toulon University
bio N com Association
Investigators
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Principal Investigator: Daniel D'AMORE, MD Centre Hospitalier Intercommunal Toulon La Seyne sur mer
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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT02843737    
Other Study ID Numbers: CH-2014-02 / IDS 2
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders