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NCT Number: NCT02913651

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

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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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Idiopathic Hypersomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Device

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

Primary outcomes

  1. High Frequencies (HF)

    Time frame: During the polysomnography (one night)

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

Secondary outcomes

  1. 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

  2. Apnea-Hypopnea Index (AIH)

    Time frame: During the polysomnography (one night)

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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