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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01698411
First received: July 12, 2012
Last updated: January 30, 2013
Last verified: July 2012

July 12, 2012
January 30, 2013
October 2012
January 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01698411 on ClinicalTrials.gov Archive Site
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.
Same as current
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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
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Probability Sample

adult with chronic complain of insomnia

  • Hypertension
  • Sleep
  • Insomnia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Both
18 Years and older
Yes
Contact: camille ly, MP 0142348025 camille.ly@htd.aphp.fr
France
 
NCT01698411
C11-57, 2012-A00825-38
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP