SleepNCT03163498
Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
An observational study of Sleep, run by Universidade Federal de Goias at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- No intervantion. It´s a Cross-Sectional Study
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2017to 6 Jan 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep
- Being tested
- No intervantion. It´s a Cross-Sectional Study
- Keywords
- Hypertension, Exercise, Sleep
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervantion. It´s a Cross-Sectional StudyOther
No intervential
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE | Participating in this group will be 30 active hypertension patients who exercise at least 3 times a week for at least 30 minutes Receives: Other: No intervantion. It´s a Cross-Sectional Study | |
| INACTIVE | Participating in this group will be 30 inactive hypertension patients who do not exercise. Receives: Other: No intervantion. It´s a Cross-Sectional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Polysomnography, Pittsburgh Sleep Quality Index
Measured: 3 months
Exercise
Normal Physical Activity Level, Pedometer
Measured: 3 months
Mood
Profile of Mood States
Measured: 3 months
Anxiety
Beck Anxiety Inventory
Measured: 3 months
Depression
Beck Depression Inventory
Measured: 3 months
Daytime drowsiness
Epworth Sleepiness Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start25 Sep 2017
- Primary completion30 Dec 2018
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Soares Passos, Universidade Federal de Goias
- Investigators
- Giselle Passos, PHD, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163498
- Sponsor's protocol ID
- 1.986.587
- Status last verified
- Mar 2020
- First submitted
- 20 May 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25328886Passos 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.
PubMed 22760906Passos 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.
PubMed 28076650
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Mood and Physical Activity Level in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT03163498
- Acronym / sponsor ID
- 1.986.587
- Conditions
- Sleep
- Keywords
- Hypertension, Exercise, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE | – | Other: No intervantion. It´s a Cross-Sectional StudyParticipating in this group will be 30 active hypertension patients who exercise at least 3 times a week for at least 30 minutes |
| INACTIVE | – | Other: No intervantion. It´s a Cross-Sectional StudyParticipating in this group will be 30 inactive hypertension patients who do not exercise. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervantion. It´s a Cross-Sectional StudyNo intervential | Other | ACTIVE, INACTIVE |
Primary outcome
Sleep
Time frame: 3 months
Polysomnography, Pittsburgh Sleep Quality Index
Exercise
Time frame: 3 months
Normal Physical Activity Level, Pedometer
Mood
Time frame: 3 months
Profile of Mood States
Anxiety
Time frame: 3 months
Beck Anxiety Inventory
Depression
Time frame: 3 months
Beck Depression Inventory
Daytime drowsiness
Time frame: 3 months
Epworth Sleepiness Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 25328886Passos 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.
- Background: PubMed 22760906Passos 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.
- Results publication: PubMed 28076650Passos 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.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giselle Passos, PHD principal investigator
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163498, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.