Clinical trial NCT06386588: The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
Official title: The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: Hippocampus
Neuromodulation
Sleep spindles
Thalamocortical circuits
Auditory stimulation
Magnetic resonance imaging
Sleep
Memory
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan.


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* Fluent in English
* Able to give informed consent

Additional inclusion for Adults with schizophrenia:

* A DSM-V confirmed diagnosis of schizophrenia
* Unmedicated or maintained on a stable dose of APDs

Exclusion Criteria:

* Ferrous metal in the body
* Currently pregnant or breastfeeding
* Motor problems that preclude finger tapping task
* IQ \<85
* Other neurological disorders, including seizure disorder
* Significant hearing or vision loss
* Chronic medical conditions that affect sleep
* Unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
* Diagnosed sleep disorder, except insomnia
* History of head injury resulting in prolonged loss of consciousness or other neurological sequelae

Additional Exclusion Criteria for Healthy adults:

* History of mental illness
* Current use of psychotropic medications or treatment with medications known to affect sleep or cognition

Primary outcomes:
measure: Changes in sleep physiology
timeFrame: across 5 nights of sleep with auditory stimulation
measure: Changes in functional connectivity of the hippocampus and thalamus
timeFrame: Approximately 1 week between baseline and follow-up scans
measure: Changes in hippocampal activation during motor sequence task (MST)
timeFrame: Approximately 1 week between baseline and follow-up scans
measure: Changes in hippocampal microstructural integrity
timeFrame: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Secondary outcomes:
measure: Greater gains in typing speed over rest breaks during MST training (micro-offline gains)
timeFrame: Approximately 5 days between pre- and post-stimulation MST administrations
measure: Sleep dependent memory consolidation (SDMC)
timeFrame: Approximately 5 days between pre- and post-stimulation MST administrations
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: