Sleep DeprivationNCT02484846
Impaired Vigilance, and Its Effects on Cognition and Behavior
A study testing Time in bed in people with Sleep Deprivation and Feeding Behavior, run by Stanford University.
Trial summary
Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. The first session was a baseline. The sleep intervention took place on the night prior to Session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Feeding Behavior
- What is being tested?
- Time in bed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Mar 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years
- BMI: 20-29 kg/m²
- Eat breakfast at least 5 days per week
- Wake time occurs between 5\&10AM at least 5 days per week
- Time in bed for sleep between 5\&10 hours at least 5 days per week
Who cannot join
- Dietary restrictions that prohibit them from selecting one of the food choices offered in the study (e.g., gluten allergies, diabetes, vegan diet, dairy avoidance, allergies to the respective food choices available),
- are currently on a calorie-restricted diet, or
- are currently at a weight that is less than 20% of their highest weight within the last three years.
- Participation in shift work within 7 nights of the experiment
- Diagnosed as having severe sleep apnea syndrome, narcolepsy or chronic insomnia
- Diagnosed as having an eating disorder
Show all 9Show fewer
- Active serious health condition
- Regularly taking vigilance-related medication (e.g., ADHD prescribed medication)
- Typically consume more than 600 mg of coffee or more than 10 cigarettes per day
About this study
Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. The first session was a baseline. The sleep intervention took place on the night prior to Session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness were measured. During the middle of each session, a 40-minute ad libitum meal opportunity allowed participants to eat from eight different food items. Food healthfulness, caloric density, distribution and number of calories were measured and compared to alertness levels.
- Conditions
- Sleep Deprivation, Feeding Behavior
- Being tested
- Time in bed
- Medical subject headings
- Sleep Deprivation, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time in bedBehavioural
Habitual time spent in bed for the purpose of sleep was determined at baseline. This was used to calculated the experimental time in bed the subject was to spent on the one night prior to the second lab visit.
| Study group | Role | What they receive |
|---|---|---|
| 60% TIB | Experimental | Participants were to spend 60% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 70% TIB | Experimental | Participants were to spend 70% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 80% TIB | Experimental | Participants were to spend 80% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 90% TIB | Experimental | Participants were to spend 90% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 100% TIB | Active comparator | Participants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 115% TIB | Experimental | Participants were to spend 115% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
| 130% TIB | Experimental | Participants were to spend 130% of their normal time in bed on the night prior to the second visit. Receives: Behavioral: Time in bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total calories consumed
Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.
Measured: 45 minutes
Secondary outcomes (1)
Alertness
Objective alertness was determined during each of the two study sessions during a 15 minute test of sustained attention (Psychomotor Vigilance Task).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484846
- Sponsor's protocol ID
- IRB-20650
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pardi D, Buman M, Black J, Lammers GJ, Zeitzer JM. Eating Decisions Based on Alertness Levels After a Single Night of Sleep Manipulation: A Randomized Clinical Trial. Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw039.
PubMed 28364494
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Vigilance, and Its Effects on Cognition and Behavior
- ClinicalTrials.gov ID
- NCT02484846
- Acronym / sponsor ID
- IRB-20650
- Conditions
- Sleep Deprivation, Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Jun 2015 (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.
Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. The first session was a baseline. The sleep intervention took place on the night prior to Session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness were measured. During the middle of each session, a 40-minute ad libitum meal opportunity allowed participants to eat from eight different food items. Food healthfulness, caloric density, distribution and number of calories were measured and compared to alertness levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 60% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 60% of their normal time in bed on the night prior to the second visit. |
| 70% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 70% of their normal time in bed on the night prior to the second visit. |
| 80% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 80% of their normal time in bed on the night prior to the second visit. |
| 90% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 90% of their normal time in bed on the night prior to the second visit. |
| 100% TIB | Active comparator | Behavioral: Time in bedParticipants were to spend 100% of their normal time in bed (i.e., no change) on the night prior to the second visit. |
| 115% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 115% of their normal time in bed on the night prior to the second visit. |
| 130% TIB | Experimental | Behavioral: Time in bedParticipants were to spend 130% of their normal time in bed on the night prior to the second visit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-45 years
- BMI: 20-29 kg/m²
- Eat breakfast at least 5 days per week
- Wake time occurs between 5\&10AM at least 5 days per week
- Time in bed for sleep between 5\&10 hours at least 5 days per week
Key exclusion criteria (9 listed)
- Dietary restrictions that prohibit them from selecting one of the food choices offered in the study (e.g., gluten allergies, diabetes, vegan diet, dairy avoidance, allergies to the respective food choices available),
- are currently on a calorie-restricted diet, or
- are currently at a weight that is less than 20% of their highest weight within the last three years.
- Participation in shift work within 7 nights of the experiment
- Diagnosed as having severe sleep apnea syndrome, narcolepsy or chronic insomnia
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 |
|---|---|---|
| Time in bedHabitual time spent in bed for the purpose of sleep was determined at baseline. This was used to calculated the experimental time in bed the subject was to spent on the one night prior to the second lab visit. | Behavioural | 100% TIB, 115% TIB, 130% TIB, 60% TIB, 70% TIB, 80% TIB, 90% TIB |
Primary outcome
Total calories consumed
Time frame: 45 minutes
Total calories consumed during a 45 minute meal opportunity during the each of the two study sessions.
1 secondary outcome
Alertness
Time frame: 15 minutes
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 30 Jun 2015.
- Derived from this study: PubMed 28364494Pardi D, Buman M, Black J, Lammers GJ, Zeitzer JM. Eating Decisions Based on Alertness Levels After a Single Night of Sleep Manipulation: A Randomized Clinical Trial. Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw039.
Related trials for Sleep Deprivation
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Time in bed in people with Sleep Deprivation and Feeding Behavior, run by Stanford University.
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 9 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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Total calories consumed (time frame: 45 minutes). 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 NCT02484846, which also lists 1 linked publication.
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 30 Jun 2015.