The Effect of Sleep Loss on Emotion Regulation

Insomnia Clinical Trial

Official title:

The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393830
• Other study ID #: 2022P000120
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: July 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Tony J Cunningham, PhD
• Phone: 617-667-3337
• Email: acunnin4[@]BIDMC.Harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

(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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• left-handedness or ambidexterity

• the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)

Related Conditions & MeSH terms

• Insomnia
• Sleep
• Sleep Deprivation
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep Restriction
Three nights of sleep restricted to 4 hours per night.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Emotional Regulation Task with Strategy	Baseline behavioral ratings to emotional stimuli with emotion regulation strategies	Day 1
Primary	Baseline Emotional Regulation Task without Strategy	Baseline behavioral ratings to emotional stimuli without emotion regulation strategies	Day 1
Primary	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	one test in a 3-6 day window
Primary	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	one test in a 3-6 day window
Secondary	Functional Magnetic Resonance Imaging (fMRI)	fMRI measured neural reactivity (blood oxygen-level dependent signal)	one test in a 3-6 day window