Other Conditions That May Be A Focus of Clinical AttentionCSRNCT01493661
Chronic Sleep Restriction
An observational study of Other Conditions That May Be A Focus of Clinical Attention, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Other Conditions That May Be A Focus of Clinical Attention
- What is being tested?
- Chronic Sleep Restriction
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Feb 2015
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Community sample, residents of Sao Paulo city
Who may be able to join
- Body Mass Index ≤ 25 kg/m2
- Physically active individuals
- 8 years of school education.
Who cannot join
- High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35
- High level of anxiety - Beck Depression Inventory ≥ 19
- PSQI - Pittsburgh Sleep Quality Index ≥ 11
- ESS - Epworth Sleepiness Scale ≥ 15
- Irregular rhythm of sleep identified by actigraphy
- Sleep disturbance by polysomnography
Show all 11Show fewer
- Shift worker or nocturnal worker;
- Obesity;
- Smoker;
- Alcohol Intake of more than 3 drinks per day;
- Taking sleep medications or illicit drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Sleep Restriction: Neurobehavioral and Physiological Responses
Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).
- Being tested
- Chronic Sleep Restriction
- Keywords
- Sleep, Polysomnography, Reaction Time, Sleep Deprivation, Psychophysiology, Chronic sleep restriction, healthy, without sleep complaints
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Sleep RestrictionOther
Also called Chronic, Sleep, Restriction
All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST Receives: Other: Chronic Sleep Restriction | |
| Group 2 | Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST Receives: Other: Chronic Sleep Restriction | |
| Group 3 | Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST Receives: Other: Chronic Sleep Restriction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Conditions That May Be A Focus of Clinical AttentionStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marco Tulio de Mello, Federal University of São Paulo
- Investigators
- Marco T De Mello, Ph.D, Principal investigator, Federal University of São PauloJuliana MS Prado, Ph.D, Study chair, Federal University of São PauloPatricia Rzezak, Ph.D, Study chair, Federal University of São PauloSergio Tufik, Ph.D, Study chair, Federal University of São PauloSandra S De Queiroz, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493661
- Sponsor's protocol ID
- CEPE2011SSQueiroz
- Acronym
- CSR
- Status last verified
- Feb 2016
- First submitted
- 14 Dec 2011
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Sleep Restriction: Neurobehavioral and Physiological Responses
- ClinicalTrials.gov ID
- NCT01493661
- Acronym / sponsor ID
- CSR / CEPE2011SSQueiroz
- Keywords
- Sleep, Polysomnography, Reaction Time, Sleep Deprivation, Psychophysiology, Chronic sleep restriction, healthy, without sleep complaints
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Dec 2011 (estimated)
- 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.
Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Chronic Sleep RestrictionMen with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST |
| Group 2 | – | Other: Chronic Sleep RestrictionMen with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST |
| Group 3 | – | Other: Chronic Sleep RestrictionMen with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample, residents of Sao Paulo city
Key inclusion criteria (3 listed)
- Body Mass Index ≤ 25 kg/m2
- Physically active individuals
- 8 years of school education.
Key exclusion criteria (11 listed)
- High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35
- High level of anxiety - Beck Depression Inventory ≥ 19
- PSQI - Pittsburgh Sleep Quality Index ≥ 11
- ESS - Epworth Sleepiness Scale ≥ 15
- Irregular rhythm of sleep identified by actigraphy
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 |
|---|---|---|
| Chronic Sleep RestrictionAlso: Chronic, Sleep, RestrictionAll volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Not reported in the source record.
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 3 Feb 2016.
- Fundação de Amparo à Pesquisa do Estado de São PauloLink provided by the sponsor.
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.
Marco T De Mello, Ph.D principal investigator
Federal University of São Paulo
Juliana MS Prado, Ph.D study chair
Federal University of São Paulo
Patricia Rzezak, Ph.D study chair
Federal University of São Paulo
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 Other Conditions That May Be A Focus of Clinical Attention, run by Federal University of São Paulo 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 3 inclusion and 11 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 3 Feb 2016. 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.
Where can I read the original study information?
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 3 Feb 2016.