NCT02843737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2014

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

10 days

First QC Date

July 20, 2016

Last Update Submit

May 11, 2017

Conditions

Sleep Fragmentation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Polysomnography under spontaneous breathingOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who performed a spontaneous breathing polysomnography

You may qualify if:

  • Spontaneous polysomnography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Dijon

Dijon, 21079, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)

Toulon, 83056, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Daniel D'AMORE, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur mer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 26, 2016

Study Start

November 21, 2014

Primary Completion

December 1, 2014

Study Completion

March 16, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

FR(3)