Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

January 24, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne
Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

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
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Idiopathic hypersomnia patients and no idiopathic hypersomnia patient

Description

Inclusion Criteria:

Idiopathic hypersomnia patients

  • idiopathic hypersomnia diagnosis
  • complaints of excessive daytime sleepiness for >1 year
  • a night-time length >10 h for 3 weeks before polysomnography as assessed by a sleep diary

Inclusion Criteria:

no idiopathic hypersomnia patients

  • no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score <10

Exclusion Criteria (both):

  • Narcolepsy-cataplexy
  • sleep irregularities and sleep deprivation symptoms
  • lack of neurological or psychiatric diseases
  • upper airway resistance syndrome
  • periodic limbs movements
  • cerebral lesion
  • medication or drinks affecting sleep and wake state

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idiopathic hypersomnia
Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15
Device: Polysomnography
The polysomnography, for both groups, was performed accordance with standard practice
Controls
Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography
Device: Polysomnography
The polysomnography, for both groups, was performed accordance with standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Frequencies (HF)
Time Frame: During the polysomnography (one night)
Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)
During the polysomnography (one night)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability (HRV)
Time Frame: During the polysomnography (one night)
HRV is measured by the polysomnography. It is a composite outcome : Standard Deviation of NN intervals (SDNN), the proportion of NN30 (and 50) divided by total number of NNs (pNN30, pNN50), Root Mean Square of Successive Differences (RMSSD), Standard Deviation type 1 and 2 (SD1, SD2), Low Frequencies (LF), Very Low Frequencies (VLF), LF/HF ratio and Ptot indexes
During the polysomnography (one night)
Apnea-Hypopnea Index (AIH)
Time Frame: During the polysomnography (one night)
During the polysomnography (one night)
Epworth Sleepiness Scale (ESS)
Time Frame: Before the polysomnography (one night)
It examines eight different situations using a 4-grade scale ranging from 0 (no chances of napping) to 3 (high chances of napping). Subjects were defined as sleepy if they had an ESS>10
Before the polysomnography (one night)

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Chair: Emilia SFORZA, MD, CHU de Saint-Etienne

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

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1600111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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