Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients

Sleep Clinical Trial

Official title:

Sleep, Mood and Physical Activity Level in Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163498
• Other study ID #: 1.986.587
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: January 6, 2020

Study information

• Verified date: March 2020
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 6, 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• No intervantion. It´s a Cross-Sectional Study
No intervential

Locations

Country	Name	City	State
Brazil	Anna Paula Ribeiro Campos	Rio Verde	GO

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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 Ja — View Citation

Outcome

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

External Links

•   World Health Organization Site