Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Study Overview
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Brief Summary
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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.

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

Conditions
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Narcolepsy, Cataplexy

Intervention / Treatment
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* Device: Polysomnography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Frequencies (HF) | 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) | 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) |  | During the polysomnography (one night) | 
| 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 | Before the polysomnography (one night) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic hypersomnia, heart rate variability, parasympathetic activity, autonomic arousal response