Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders (HATS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01698411|
Recruitment Status : Unknown
Verified July 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : October 3, 2012
Last Update Posted : January 31, 2013
|Condition or disease|
|Hypertension Sleep Insomnia|
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 Type :||Observational|
|Estimated Enrollment :||305 participants|
|Official Title:||Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
- hypertension [ Time Frame: 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
- hemodynamic measures [ Time Frame: one year ]central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.
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): 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|