Clincosm LogoSign in Get a demo

HATS: Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT01698411
Collaborator
(none)
90
Enrollment
1
Location
28
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Several epidemiological studies in large cohorts suggest a strong association between sleep duration, complaint of insomnia and risk of hypertension.These findings suggest an important role of sleep quality in development of hypertension. Principal limitations of these studies are the cross-sectional study design, self-report sleep duration and poor measurement of blood pressure. The investigators propose to study an insomniac population with complete evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement of hypertension.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with chronic complain of insomnia. In our study, sleep duration is evaluated by complete evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.

    The primary objective of this epidemiological study is to show an increase risk of hypertension when sleep duration is less than 7 hours, with objective measurement of sleep duration and hypertension.

    Secondary objectives are to evaluate role of complain of insomnia in the risk of hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2015
    Actual Study Completion Date :
    Feb 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. hypertension [one year]

      hypertension is defined by blood pressure obtained with 24 hours ambulatory blood pressure measurement when mean blood pressure is over 135/80 in the day, and 125/70 in the night, or when patient take antihypertensive drugs

    Secondary Outcome Measures

    1. hemodynamic measures [one year]

      central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • adult with insomnia (6 months or more)
    Exclusion Criteria:
    • sleep disorders with obstructive apnea

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 centre du sommeil et de la vigilance, Hotel Dieu Paris France 75004

    Sponsors and Collaborators

    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    • Principal Investigator: jacques blacher, professor, Institut National de la Santé Et de la Recherche Médicale, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT01698411
    Other Study ID Numbers:
    • C11-57
    • 2012-A00825-38
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France
    hypertension
    sleep
    insomnia
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Sleep Wake Disorders
    Parasomnias
    Hypertension

    Study Results

    No Results Posted as of Aug 26, 2021