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

This study is currently recruiting participants.
Verified July 2012 by Institut National de la Santé Et de la Recherche Médicale, France
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
History of Changes
  Purpose

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
Hypertension
Sleep
Insomnia

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 305
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 12, 2012
Last Updated: January 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on June 18, 2013