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Clinical Trials/NCT02843737
NCT02843737CompletedNot Applicable

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

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer3 sites in 1 country300 target enrollmentStarted: November 21, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
3
Primary Endpoint
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing

Study Overview

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.

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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Spontaneous polysomnography

Exclusion Criteria

  • Patients with psychoactive drug having an important effect on sleep

Outcomes

Primary Outcomes

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 .

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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