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CompletedNCT02913651Updated Jan 25, 2017

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

An observational study in Narcolepsy and Cataplexy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
33
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Narcolepsy
  • Cataplexy

Keywords

  • Idiopathic hypersomnia
  • heart rate variability
  • parasympathetic activity
  • autonomic arousal response
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In context

Narcolepsy

152 studies on the registry are indexed under Narcolepsy; 32 are open to participants now.

This study's enrollment of 33 is below the median of 120 across 36 observational studies indexed under Narcolepsy.

Browse Narcolepsy studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Idiopathic hypersomnia patients and no idiopathic hypersomnia patient

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
33 participants (actual)
Patient registry
No

Groups and cohorts

  • Idiopathic hypersomnia

    Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15

    Device: Polysomnography

  • Controls

    Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography

    Device: Polysomnography

Interventions

  • DevicePolysomnography

    The polysomnography, for both groups, was performed accordance with standard practice

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What researchers measure

Primary outcomes

  1. High Frequencies (HF)

    Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)

    Time frame: During the polysomnography (one night)

Secondary outcomes

  1. Heart rate variability (HRV)

    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

    Time frame: During the polysomnography (one night)

  2. Apnea-Hypopnea Index (AIH)

    Time frame: During the polysomnography (one night)

  3. Epworth Sleepiness Scale (ESS)

    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

    Time frame: Before the polysomnography (one night)

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Study locations

1 site
  • CHU de SAINT-ETIENNE
    Saint-Etienne, 42000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02913651
Responsible party
Sponsor
First posted
Sep 26, 2016
Start date
Jan 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 25, 2017

Study contacts

Emilia SFORZA, MD
study chair · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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