Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders (HATS)
Recruitment status was: Recruiting
|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
|centre du sommeil et de la vigilance, Hotel Dieu|
|France, Paris, France, 75004|
|Principal Investigator:||jacques blacher, professor||Institut National de la Santé Et de la Recherche Médicale, France|