Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders (HATS)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort|
|Official Title:||Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders|
- hypertension [ Time Frame: one year ] [ Designated as safety issue: Yes ]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
- hemodynamic measures [ Time Frame: one year ] [ Designated as safety issue: Yes ]central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698411
|Contact: camille ly, MPfirstname.lastname@example.org|
|centre du sommeil et de la vigilance, Hotel Dieu||Recruiting|
|France, Paris, France, 75004|
|Contact: camille ly, cca 0742348966 email@example.com|
|Sub-Investigator: camille ly, cca|
|Sub-Investigator: olympe veron, cca|
|Sub-Investigator: damien leger, professeur|
|Principal Investigator:||jacques blacher, professor||Institut National de la Santé Et de la Recherche Médicale, France|