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Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02913651
Enrollment
33
Registered
2016-09-26
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataplexy, Narcolepsy

Keywords

Idiopathic hypersomnia, heart rate variability, parasympathetic activity, autonomic arousal response

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.

Interventions

DEVICEPolysomnography

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
High Frequencies (HF)During the polysomnography (one night)Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)

Secondary

MeasureTime frameDescription
Heart rate variability (HRV)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)During the polysomnography (one night)
Epworth Sleepiness Scale (ESS)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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026