Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Completed

• Conditions: Narcolepsy; Cataplexy
• Interventions: Device: Polysomnography

• Registration Number: NCT02913651
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Polysomnography	Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography
Idiopathic hypersomnia	Polysomnography	Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15

Primary Outcome Measures

Name	Time	Method
High Frequencies (HF)	During the polysomnography (one night)	Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France