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

Sleep Fragmentation Clinical Trial

— SDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843737
• Other study ID #: CH-2014-02 / IDS 2
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: May 11, 2017
• Start date: November 21, 2014
• Est. completion date: March 16, 2017

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 16, 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spontaneous polysomnography

Exclusion Criteria:

• Insomnia

• Patients with psychoactive drug having an important effect on sleep

Related Conditions & MeSH terms

• Sleep Deprivation
• Sleep Fragmentation

Intervention

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

Locations

Country	Name	City	State
France	CHU Dijon	Dijon
France	CHU Poitiers	Poitiers
France	Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)	Toulon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	bio N com Association, Toulon University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing	In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index .	One night