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NCT01698411 Clinical Trial

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

Hypertension Clinical Trial

— HATS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01698411
Other study ID # C11-57
Secondary ID 2012-A00825-38
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date February 2015

Study information
Verified date August 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - adult with insomnia (6 months or more) Exclusion Criteria: - sleep disorders with obstructive apnea

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France centre du sommeil et de la vigilance, Hotel Dieu Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary hypertension 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 one year
Secondary hemodynamic measures central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability. one year
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