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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698411
First Posted: October 3, 2012
Last Update Posted: January 31, 2013
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.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
July 12, 2012
October 3, 2012
January 31, 2013
October 2012
January 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01698411 on ClinicalTrials.gov Archive Site
hemodynamic measures [ Time Frame: one year ]
central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.
Same as current
Not Provided
Not Provided
 
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
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.

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.

Observational
Observational Model: Cohort
Not Provided
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Probability Sample
adult with chronic complain of insomnia
  • Hypertension
  • Sleep
  • Insomnia
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
305
January 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult with insomnia (6 months or more)

Exclusion Criteria:

  • sleep disorders with obstructive apnea
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01698411
C11-57
2012-A00825-38 ( Registry Identifier: IDRCB )
No
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Principal Investigator: jacques blacher, professor Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
July 2012