Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

NCT02913651 | Completed

• 1 other identifier: 1600111
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy; Cataplexy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• High Frequencies (HF)

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

  During the polysomnography (one night)

Secondary Outcomes (3)

• Heart rate variability (HRV)

  During the polysomnography (one night)

• Apnea-Hypopnea Index (AIH)

  During the polysomnography (one night)

• Epworth Sleepiness Scale (ESS)

  Before the polysomnography (one night)

Study Arms (2)

Idiopathic hypersomnia

Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15

Device: Polysomnography

Controls

Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography

Device: Polysomnography

Interventions

Polysomnography DEVICE

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

Controls; Idiopathic hypersomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Idiopathic hypersomnia patients and no idiopathic hypersomnia patient

You may qualify if:

• 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
• no idiopathic hypersomnia patients
• no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score \<10

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Idiopathic Hypersomnia

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emilia SFORZA, MD

  CHU de SAINT-ETIENNE

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)