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OpenTrials
Completed

NCT Number: NCT03163498

Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients

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.

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Key information

Conditions

Sleep Behavior Cardiovascular Diseases Hypertension Motor Activity Vascular Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Anna Paula Ribeiro Campos

Rio Verde, Goiás, 75906-805, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervantion. It´s a Cross-Sectional Study

Other

No intervential

Primary outcomes

  1. Sleep

    Time frame: 3 months

    Polysomnography, Pittsburgh Sleep Quality Index

  2. Exercise

    Time frame: 3 months

    Normal Physical Activity Level, Pedometer

  3. Mood

    Time frame: 3 months

    Profile of Mood States

  4. Anxiety

    Time frame: 3 months

    Beck Anxiety Inventory

  5. Depression

    Time frame: 3 months

    Beck Depression Inventory

  6. Daytime drowsiness

    Time frame: 3 months

    Epworth Sleepiness Scale

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Registry information

Official study title

Sleep, Mood and Physical Activity Level in Patients With Hypertension

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 23, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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