Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI) (SDI)

May 11, 2017 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon
      • Poitiers, France, 86021
        • CHU Poitiers
      • Toulon, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who performed a spontaneous breathing polysomnography

Description

Inclusion Criteria:

  • Spontaneous polysomnography

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
One night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Toulon University
bio N com Association

Investigators

  • Principal Investigator: Daniel D'AMORE, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-2014-02 / IDS 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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