Clinical Trial: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Brief 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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: High Frequencies (HF) [ Time Frame: During the polysomnography (one night) ]

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


Original Primary Outcome: High Frequencies (HF) [ Time Frame: During the polysomnography ]

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


Current Secondary Outcome:

  • 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
  • Apnea-Hypopnea Index (AIH) [ Time Frame: 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


Original Secondary Outcome:

  • Heart rate variability (HRV) [ Time Frame: During the polysomnography ]
    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
  • Apnea-Hypopnea Index (AIH) [ Time Frame: During the polysomnography ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Before the polysomnography ]
    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


Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: September 22, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 24, 2017
Last Verified: September 2016