SleepNCT05393830
The Effect of Sleep Loss on Emotion Regulation
A study testing Sleep Restriction in people with Sleep and Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Insomnia, Sleep Deprivation
- What is being tested?
- Sleep Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing and able to follow the protocol
- willing and able to meet inclusion criteria for fMRI scanning
- willing to refrain from alcohol and recreational drugs for the duration of the protocol
- normal or corrected to normal vision is required
Who cannot join
- left-handedness or ambidexterity
- the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Tony Cunningham, PhD, 617-667-4702, acunnin4@bidmc.harvard.edu
Janet Mullington, PhD, 617-667-0434, jmulling@BIDMC.Harvard.edu
About this study
Official title: The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions.
(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
Read the detailed description
Goal 1: How does sleep loss and clinical sleep disruption (i.e. Insomnia Disorder) impact emotion perception and emotion regulation? The investigators are interested in how chronic loss of sleep, either through artificially restricting sleep or clinically related sleep disturbance, impairs our ability to properly perceive and regulate our responses to emotional information using various emotion regulation strategies. There has been research on the effect of sleep loss on broad areas of cognition, such as attention, working memory, and reasoning ability, but the impact of long-term sleep loss on emotional processing and regulation remains largely unexplored. The investigators aim to characterize how sleep loss via experimentally reduced sleep in healthy control participants or clinical sleep disturbance in patients with Insomnia Disorder, affects the ability to accurately perceive emotion. Investigators will also investigate how it alters the intensity with which emotions are perceived, and the effect that these changes have on the ability to regulate emotional responses to these stimuli compared to healthy control participants that are allowed undisturbed sleep.
Goal 2: How are changes in subjective emotional responses reflected in the neural signal and psychophysiological measures? The investigators will utilize fMRI and measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural and psychophysiological responses that are associated with behavioral changes following sleep restriction or in patients with Insomnia disorder compared to healthy sleep control participants.
- Conditions
- Sleep, Insomnia, Sleep Deprivation
- Being tested
- Sleep Restriction
- Keywords
- Emotion, Sleep Restriction, Insomnia Disorder, Sleep, Emotion Regulation, functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep RestrictionBehavioural
Three nights of sleep restricted to 4 hours per night.
| Study group | Role | What they receive |
|---|---|---|
| Normal Sleep | No intervention | Normal Sleep - Healthy participants are permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning |
| Sleep Restriction | Active comparator | Healthy Participants are sleep restricted to 4 hours of sleep for 3 consecutive days before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning Receives: Behavioral: Sleep Restriction |
| Patients with Insomnia Disorder | No intervention | Patients with Insomnia Disorder will also be recruited and will be permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Emotional Regulation Task with Strategy
Baseline behavioral ratings to emotional stimuli with emotion regulation strategies
Measured: Day 1
Baseline Emotional Regulation Task without Strategy
Baseline behavioral ratings to emotional stimuli without emotion regulation strategies
Measured: Day 1
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Behavioral ratings to emotional stimuli with emotion regulation strategies following normal sleep or sleep restriction
Measured: one test in a 3-6 day window
Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction
Measured: one test in a 3-6 day window
Secondary outcomes (1)
Functional Magnetic Resonance Imaging (fMRI)
fMRI measured neural reactivity (blood oxygen-level dependent signal)
Measured: one test in a 3-6 day window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start11 May 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Independent Groups Comparison
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Cunningham, Beth Israel Deaconess Medical Center
- Investigators
- Janet M Mullington, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393830
- Sponsor's protocol ID
- 2022P000120
- Status last verified
- Apr 2026
- First submitted
- 20 May 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are developing our institutional data sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation
- ClinicalTrials.gov ID
- NCT05393830
- Acronym / sponsor ID
- 2022P000120
- Conditions
- Sleep, Insomnia, Sleep Deprivation
- Keywords
- Emotion, Sleep Restriction, Insomnia Disorder, Sleep, Emotion Regulation, functional Magnetic Resonance Imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 26 May 2022 (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.
The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions.
(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
Detailed description
Goal 1: How does sleep loss and clinical sleep disruption (i.e. Insomnia Disorder) impact emotion perception and emotion regulation? The investigators are interested in how chronic loss of sleep, either through artificially restricting sleep or clinically related sleep disturbance, impairs our ability to properly perceive and regulate our responses to emotional information using various emotion regulation strategies. There has been research on the effect of sleep loss on broad areas of cognition, such as attention, working memory, and reasoning ability, but the impact of long-term sleep loss on emotional processing and regulation remains largely unexplored. The investigators aim to characterize how sleep loss via experimentally reduced sleep in healthy control participants or clinical sleep disturbance in patients with Insomnia Disorder, affects the ability to accurately perceive emotion. Investigators will also investigate how it alters the intensity with which emotions are perceived, and the effect that these changes have on the ability to regulate emotional responses to these stimuli compared to healthy control participants that are allowed undisturbed sleep.
Goal 2: How are changes in subjective emotional responses reflected in the neural signal and psychophysiological measures? The investigators will utilize fMRI and measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural and psychophysiological responses that are associated with behavioral changes following sleep restriction or in patients with Insomnia disorder compared to healthy sleep control participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Independent Groups Comparison
| Arm | Type | Receives |
|---|---|---|
| Normal Sleep | No intervention | –Normal Sleep - Healthy participants are permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning |
| Sleep Restriction | Active comparator | Behavioral: Sleep RestrictionHealthy Participants are sleep restricted to 4 hours of sleep for 3 consecutive days before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning |
| Patients with Insomnia Disorder | No intervention | –Patients with Insomnia Disorder will also be recruited and will be permitted normal nights of polysomnography or actigraphy recorded sleep before participating in an emotion regulation task during functional Magnetic Resonance Imaging (fMRI) scanning |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- willing and able to follow the protocol
- willing and able to meet inclusion criteria for fMRI scanning
- willing to refrain from alcohol and recreational drugs for the duration of the protocol
- normal or corrected to normal vision is required
Key exclusion criteria (2 listed)
- left-handedness or ambidexterity
- the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)
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 |
|---|---|---|
| Sleep RestrictionThree nights of sleep restricted to 4 hours per night. | Behavioural | Sleep Restriction |
Primary outcome
Baseline Emotional Regulation Task with Strategy
Time frame: Day 1
Baseline behavioral ratings to emotional stimuli with emotion regulation strategies
Baseline Emotional Regulation Task without Strategy
Time frame: Day 1
Baseline behavioral ratings to emotional stimuli without emotion regulation strategies
Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Time frame: one test in a 3-6 day window
Behavioral ratings to emotional stimuli with emotion regulation strategies following normal sleep or sleep restriction
Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies
Time frame: one test in a 3-6 day window
Behavioral ratings to emotional stimuli without emotion regulation strategies following normal sleep or sleep restriction
1 secondary outcome
Functional Magnetic Resonance Imaging (fMRI)
Time frame: one test in a 3-6 day window
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. We are developing our institutional data sharing plan
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
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.
Janet M Mullington, 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 Sleep Restriction in people with Sleep and Insomnia, 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 2 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tony J Cunningham, PhD (617-667-3337, acunnin4@BIDMC.Harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Emotional Regulation Task with Strategy (time frame: Day 1). The study lists 4 primary outcomes in all. 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 Apr 2026.