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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02843737
Acronym
SDI
Enrollment
300
Registered
2016-07-26
Start date
2014-11-21
Completion date
2017-03-16
Last updated
2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Fragmentation

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.

Interventions

OTHERPolysomnography under spontaneous breathing

Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician

Sponsors

Toulon University
CollaboratorUNKNOWN
bio N com Association
CollaboratorUNKNOWN
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Spontaneous polysomnography

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathingOne nightIn order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026