Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Narcolepsy Clinical Trial

Official title:

Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913651
• Other study ID #: 1600111
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: January 24, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataplexy
• Disorders of Excessive Somnolence
• Narcolepsy

Intervention

Device:
• Polysomnography
The polysomnography, for both groups, was performed accordance with standard practice

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Frequencies (HF)	Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)	During the polysomnography (one night)
Secondary	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)
Secondary	Apnea-Hypopnea Index (AIH)		During the polysomnography (one night)
Secondary	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)