HealthyNCT01523691
Repeating Patterns of Sleep Restriction and Recovery
A study testing Repeated sleep restriction and recovery in people with Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Repeated sleep restriction and recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2016
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 30 kg/m2
- For female participants: regular menstrual cycles
- Daily sleep duration in the normal range
- Blood chemistry in the normal range
Who cannot join
- Active infection/disease
- History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
- Pregnant/nursing
- Respiratory disturbance index of >5 events/hour on polysomnographic sleep study, leg movements with arousal >10/hour; sleep efficiency <80%
- Regular medication use other than oral contraceptives
- Donation of blood or platelets 3 month prior to or in-between study arms
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?
Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.
- Conditions
- Healthy
- Being tested
- Repeated sleep restriction and recovery, Control sleep
- Keywords
- Healthy individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated sleep restriction and recoveryBehavioural
Repeated cycles of sleep restriction and sleep recovery
Control sleepBehavioural
Regular amounts of sleep across study protocol
| Study group | Role | What they receive |
|---|---|---|
| repeated sleep restriction and recovery | Experimental | Not described Receives: Behavioral: Repeated sleep restriction and recovery |
| control sleep | Experimental | Not described Receives: Behavioral: Control sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress-related markers
cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others
Measured: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Secondary outcomes (1)
subjective stress-related markers
Computerized rating scales for the assessment of physical and emotional well-being
Measured: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Monika Haack, Beth Israel Deaconess Medical Center
- Investigators
- Monika Haack, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523691
- Sponsor's protocol ID
- 2010P000399
- Other IDs
- R01HL105544-01A1
- Status last verified
- Mar 2017
- First submitted
- 30 Nov 2011
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?
- ClinicalTrials.gov ID
- NCT01523691
- Acronym / sponsor ID
- 2010P000399
- Conditions
- Healthy
- Keywords
- Healthy individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Feb 2012 (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.
Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repeated sleep restriction and recovery | Experimental | Behavioral: Repeated sleep restriction and recovery |
| control sleep | Experimental | Behavioral: Control sleep |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18.5 and 30 kg/m2
- For female participants: regular menstrual cycles
- Daily sleep duration in the normal range
- Blood chemistry in the normal range
Key exclusion criteria (6 listed)
- Active infection/disease
- History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
- Pregnant/nursing
- Respiratory disturbance index of >5 events/hour on polysomnographic sleep study, leg movements with arousal >10/hour; sleep efficiency <80%
- Regular medication use other than oral contraceptives
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 |
|---|---|---|
| Repeated sleep restriction and recoveryRepeated cycles of sleep restriction and sleep recovery | Behavioural | repeated sleep restriction and recovery |
| Control sleepRegular amounts of sleep across study protocol | Behavioural | control sleep |
Primary outcome
stress-related markers
Time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others
1 secondary outcome
subjective stress-related markers
Time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
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 14 Mar 2017.
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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.
Monika Haack, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated sleep restriction and recovery in people with Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 4 inclusion and 6 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 14 Mar 2017. 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 United States. 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?
stress-related markers (time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.). It is what the study was designed to measure, not a finding.
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 14 Mar 2017.