Sleep DeprivationNCT04211506
Comparison Across Multiple Types of Sleep Deprivation
A study of Sleep Deprivation and Sleep Restriction, run by Civil Aerospace Medical Institute at 2 sites in United States.
Trial summary
This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2020to 12 Sep 2023
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI 18.5-29.9, with consideration of BMIs 30-34.9.
Who cannot join
- Medication use, with potential consideration for contraceptives.
- Color blindness
- Recent nightwork, shiftwork, or travel across greater than two time zones
- Pregnant or within 6 months post-partum
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
FAA Civil Aerospace Medical Institute
Oklahoma City, Oklahoma, 73169
About this study
This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.
Read the detailed description
During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. Subjects will be randomly assigned to each condition group. During their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. Additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.
- Conditions
- Sleep Deprivation, Sleep Restriction
- Being tested
- Controlled sleep
- Keywords
- Neurobehavioral performance, Genetic
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled sleepBehavioural
Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Arm 1 | Experimental | This will be the first of four arms of controlled sleep manipulation. Receives: Behavioral: Controlled sleep |
| Sleep Arm 2 | Experimental | This will be the second of four arms of controlled sleep manipulation. Receives: Behavioral: Controlled sleep |
| Sleep Arm 3 | Experimental | This will be the third of four arms of controlled sleep manipulation. Receives: Behavioral: Controlled sleep |
| Sleep Arm 4 | Experimental | This will be the fourth of four arms of controlled sleep manipulation. Receives: Behavioral: Controlled sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression changes associated with different sleep patterns.
Levels of expression of all genes may be compared across time and among study arms with different sleep patterns using RNA-Seq and differential expression analysis with generalized linear models. Patterns may be sought with and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.
Measured: Samples for gene expression will be collected at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told sampling frequency.
Secondary outcomes (2)
Neurobehavioral performance changes associated with different sleep patterns.
Neurobehavioral performance may be compared across time and among study arms with different sleep patterns. Specifically, differences will be examined in subjective and objective neurobehavioral assays (Karolinska sleepiness scale, Performance effort and evaluation rating scale, Digit symbol substitution test, Stroop performance, Raven matrix task, Comparative visual search, Face-name task, Psychomotor vigilance test, Visual analog scale, Track test, and the Balloon analog risk task). Patterns may be sought with relevance to sleep, circadian rhythms, and/or other outcome measures.
Measured: Neurobehavioral assays may be conducted at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told assay frequency.
DNA genetic variants associated with sleep and/or neurobehavioral performance.
Analysis of genetic variants may be used to assess inherited genetic differences among subjects and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.
Measured: Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start25 Aug 2020
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Civil Aerospace Medical Institute
- Sponsor type
- US federal agency
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Hilary Uyhelji, PhD, Principal investigator, FAA Civil Aerospace Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211506
- Sponsor's protocol ID
- GEN10025
- Status last verified
- Sep 2023
- First submitted
- 5 Dec 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw genetic data that form the basis of a manuscript are expected to be made available after publication in accordance with federal and IRB policy and restrictions.
Publications
Uyhelji HA, Nicholson SJ, Nesthus TE, Beckel JL, Klerman EB, Czeisler CA, Yuan RK, Arrona-Palacios A, Song P, Ronda JM, Goodson MS. Exploratory development of biomarkers for neurobehavioral performance impairment during sleep loss: comparison across multiple types of sleep deprivation. BMC Genomics. 2025 Nov 14;26(1):1043. doi: 10.1186/s12864-025-12193-6.
PubMed 41239200
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Across Multiple Types of Sleep Deprivation
- ClinicalTrials.gov ID
- NCT04211506
- Acronym / sponsor ID
- GEN10025
- Conditions
- Sleep Deprivation, Sleep Restriction
- Keywords
- Neurobehavioral performance, Genetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Civil Aerospace Medical InstituteUS federal agency
- Collaborators
- Brigham and Women's Hospital
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 26 Dec 2019 (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.
This study is designed to assess neurobehavioral performance, as well as genetic and other physiological changes associated with variations in timing and quantity of sleep.
Detailed description
During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel sleep conditions. Subjects will be randomly assigned to each condition group. During their time in the laboratory, biological samples (e.g., blood) will be collected for genetic and other analyses, and sleep quantity and quality will be monitored. Additionally responses on neurobehavioral tests and surveys will be monitored for differences among the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
| Arm | Type | Receives |
|---|---|---|
| Sleep Arm 1 | Experimental | Behavioral: Controlled sleepThis will be the first of four arms of controlled sleep manipulation. |
| Sleep Arm 2 | Experimental | Behavioral: Controlled sleepThis will be the second of four arms of controlled sleep manipulation. |
| Sleep Arm 3 | Experimental | Behavioral: Controlled sleepThis will be the third of four arms of controlled sleep manipulation. |
| Sleep Arm 4 | Experimental | Behavioral: Controlled sleepThis will be the fourth of four arms of controlled sleep manipulation. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- BMI 18.5-29.9, with consideration of BMIs 30-34.9.
Key exclusion criteria (4 listed)
- Medication use, with potential consideration for contraceptives.
- Color blindness
- Recent nightwork, shiftwork, or travel across greater than two time zones
- Pregnant or within 6 months post-partum
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 |
|---|---|---|
| Controlled sleepDuration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals. | Behavioural | Sleep Arm 1, Sleep Arm 2, Sleep Arm 3, Sleep Arm 4 |
Primary outcome
Gene expression changes associated with different sleep patterns.
Time frame: Samples for gene expression will be collected at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told sampling frequency.
Levels of expression of all genes may be compared across time and among study arms with different sleep patterns using RNA-Seq and differential expression analysis with generalized linear models. Patterns may be sought with and potential relevance to sleep, circadian rhythms, and/or neurobehavioral performance.
2 secondary outcomes
Neurobehavioral performance changes associated with different sleep patterns.
Time frame: Neurobehavioral assays may be conducted at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told assay frequency.
DNA genetic variants associated with sleep and/or neurobehavioral performance.
Time frame: Approximately two oral samples may be taken for DNA analyses during the 10 days in a sleep laboratory.
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 29 Sep 2023.
- Derived from this study: PubMed 41239200Uyhelji HA, Nicholson SJ, Nesthus TE, Beckel JL, Klerman EB, Czeisler CA, Yuan RK, Arrona-Palacios A, Song P, Ronda JM, Goodson MS. Exploratory development of biomarkers for neurobehavioral performance impairment during sleep loss: comparison across multiple types of sleep deprivation. BMC Genomics. 2025 Nov 14;26(1):1043. doi: 10.1186/s12864-025-12193-6.
- Individual participant dataSharing planned: Yes. Raw genetic data that form the basis of a manuscript are expected to be made available after publication in accordance with federal and IRB policy and restrictions.
Related trials for Sleep Deprivation
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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.
Hilary Uyhelji, PhD principal investigator
FAA Civil Aerospace Medical Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sleep Deprivation and Sleep Restriction, run by Civil Aerospace Medical Institute at 2 sites 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 2 inclusion and 4 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Gene expression changes associated with different sleep patterns. (time frame: Samples for gene expression will be collected at frequent intervals over 10 days in a sleep laboratory. Subjects will be in a time-free environment, and not told sampling frequency.). 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 NCT04211506, 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 29 Sep 2023.