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

Completed

• Conditions: Hypertension; Sleep; Insomnia

• Registration Number: NCT01698411
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

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 Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-09-28
• Study Start: 2012-10
• Study First Posted: 2012-10-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• adult with insomnia (6 months or more)

Exclusion Criteria

• sleep disorders with obstructive apnea

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hypertension	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

Name	Time	Method
hemodynamic measures	one year	central blood pressure, pathway velocity, blood pressure amplification, visit-to-visit variability of blood pressure, cardiac rhythm variability.

Trial Locations

Locations (1)

centre du sommeil et de la vigilance, Hotel Dieu; 🇫🇷 Paris, France