Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients

Sleep, Mood and Physical Activity Level in Patients With Hypertension

Introduction: Sleep disturbances may contribute to impairments in mood, occupational and intellectual performance, and social relationships, as well as being associated with cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been associated with poor sleep quality and hypertension; regular exercise has been studied as a coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare sleep pattern of active and inactive patients with arterial hypertension, as well as to evaluate complaints of depression and anxiety, and the mood profile. Material and Methods: Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS). The level of physical activity will be recorded by the number of steps taken (pedometer). Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30). Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and fewer complaints of depression and anxiety when compared to physically inactive hypertensive patients.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: No intervantion. It´s a Cross-Sectional Study

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Rio Verde, GO, Brazil, 75906-805
      • Anna Paula Ribeiro Campos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Participating in the study will be 60 males hypertension patients (ACTIVE, n=30; INACTIVE, n=30) with age between 30 and 60 years old. All participants should be under antihypertensive drug treatment.

Description

Inclusion Criteria:

• Diagnosis of systemic arterial hypertension, according to the VII Brazilian Guidelines for Hypertension;
• male;
• BMI <30;
• Age between 30 and 60 years;
• Minimum level of education: elementary school

Exclusion Criteria:

• Present pathologies in the musculoskeletal and neurological systems, or incapacitating complaints in these systems;
• Diagnosis of psychiatric disorder;
• Being under medical treatment for insomnia or other psychiatric treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACTIVE; Participating in this group will be 30 active hypertension patients who exercise at least 3 times a week for at least 30 minutes	Other: No intervantion. It´s a Cross-Sectional Study; No intervential
INACTIVE; Participating in this group will be 30 inactive hypertension patients who do not exercise.	Other: No intervantion. It´s a Cross-Sectional Study; No intervential

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Polysomnography, Pittsburgh Sleep Quality Index	3 months
Exercise	Normal Physical Activity Level, Pedometer	3 months
Mood	Profile of Mood States	3 months
Anxiety	Beck Anxiety Inventory	3 months
Depression	Beck Depression Inventory	3 months
Daytime drowsiness	Epworth Sleepiness Scale	3 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias
• Investigators: Principal Investigator: Giselle Passos, PHD, World Health Organization

Publications and helpful links

General Publications

• Passos GS, Poyares D, Santana MG, Teixeira AA, Lira FS, Youngstedt SD, dos Santos RV, Tufik S, de Mello MT. Exercise improves immune function, antidepressive response, and sleep quality in patients with chronic primary insomnia. Biomed Res Int. 2014;2014:498961. doi: 10.1155/2014/498961. Epub 2014 Sep 21.
• Passos GS, Poyares DL, Santana MG, Tufik S, Mello MT. Is exercise an alternative treatment for chronic insomnia? Clinics (Sao Paulo). 2012;67(6):653-60. doi: 10.6061/clinics/2012(06)17.
• Passos GS, Santana MG, Poyares D, D'Aurea CV, Teixeira AA, Tufik S, de Mello MT. Chronotype and anxiety are associated in patients with chronic primary insomnia. Braz J Psychiatry. 2017 Apr-Jun;39(2):183-186. doi: 10.1590/1516-4446-2016-2007. Epub 2017 Jan 9.

Helpful Links

• World Health Organization Site

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2017
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): January 6, 2020

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: May 20, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Hypertension; Sleep
• Other Study ID Numbers: 1.986.587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No