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

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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Hypertension Sleep Insomnia

Detailed Description:

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 Design

Study Type : Observational
Estimated Enrollment : 305 participants
Observational Model: Cohort
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. hemodynamic measures [ Time Frame: one year ]
    central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
adult with chronic complain of insomnia
Criteria

Inclusion Criteria:

  • adult with insomnia (6 months or more)

Exclusion Criteria:

  • sleep disorders with obstructive apnea
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: camille ly, MP 0142348025 camille.ly@htd.aphp.fr

Locations
France
centre du sommeil et de la vigilance, Hotel Dieu Recruiting
France, Paris, France, 75004
Contact: camille ly, cca    0742348966    camille.ly@htd.aphp.fr   
Sub-Investigator: camille ly, cca         
Sub-Investigator: olympe veron, cca         
Sub-Investigator: damien leger, professeur         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: jacques blacher, professor Institut National de la Santé Et de la Recherche Médicale, France
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01698411     History of Changes
Other Study ID Numbers: C11-57
2012-A00825-38 ( Registry Identifier: IDRCB )
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: July 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
hypertension
sleep
insomnia

Additional relevant MeSH terms:
Hypertension
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms