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Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

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ClinicalTrials.gov Identifier: NCT02913651
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Narcolepsy Cataplexy Device: Polysomnography

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Idiopathic hypersomnia
Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15
Device: Polysomnography
The polysomnography, for both groups, was performed accordance with standard practice

Controls
Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography
Device: Polysomnography
The polysomnography, for both groups, was performed accordance with standard practice




Primary Outcome Measures :
  1. High Frequencies (HF) [ Time Frame: During the polysomnography (one night) ]
    Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)


Secondary Outcome Measures :
  1. Heart rate variability (HRV) [ Time Frame: 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

  2. Apnea-Hypopnea Index (AIH) [ Time Frame: During the polysomnography (one night) ]
  3. Epworth Sleepiness Scale (ESS) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic hypersomnia patients and no idiopathic hypersomnia patient
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913651


Locations
France
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Study Chair: Emilia SFORZA, MD CHU de SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02913651     History of Changes
Other Study ID Numbers: 1600111
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Idiopathic hypersomnia
heart rate variability
parasympathetic activity
autonomic arousal response

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders