SchizophreniaNCT06386588
The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
A study testing Closed loop auditory stimulation during sleep in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Closed loop auditory stimulation during sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to 31 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
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
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Dara Manoach, PhD, 617-724-6148, manoachlab@gmail.com
Lindsey Jones, MS, 617-702-2368, manoachlab@gmail.com
About this study
Official title: The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- Closed loop auditory stimulation during sleep
- Keywords
- Hippocampus, Neuromodulation, Sleep spindles, Thalamocortical circuits, Auditory stimulation, Magnetic resonance imaging, Sleep, Memory
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop auditory stimulation during sleepOther
Short bursts of pink noise delivered at precise times during overnight sleep at home.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Experimental | Adult outpatients with a diagnosis of schizophrenia. Receives: Other: Closed loop auditory stimulation during sleep |
| Healthy Controls | Active comparator | Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Receives: Other: Closed loop auditory stimulation during sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep physiology
Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband
Measured: across 5 nights of sleep with auditory stimulation
Changes in functional connectivity of the hippocampus and thalamus
Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI
Measured: Approximately 1 week between baseline and follow-up scans
Changes in hippocampal activation during motor sequence task (MST)
Changes in hippocampal activation during the MST as measured by functional MRI
Measured: Approximately 1 week between baseline and follow-up scans
Changes in hippocampal microstructural integrity
Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI
Measured: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Secondary outcomes (2)
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)
MST training sessions prior to sleep consisting of typing trials separated by rest periods. We will measure typing speed before and after rest breaks.
Measured: Approximately 5 days between pre- and post-stimulation MST administrations
Sleep dependent memory consolidation (SDMC)
Comparison of SDMC between the Baseline MST only and MST with CLASS nights
Measured: Approximately 5 days between pre- and post-stimulation MST administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara S. Manoach, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386588
- Sponsor's protocol ID
- 2024P000610
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Auditory Stimulation During Sleep on Offline Learning and Thalamocortical-hippocampal Connectivity in Schizophrenia
- ClinicalTrials.gov ID
- NCT06386588
- Acronym / sponsor ID
- 2024P000610
- Conditions
- Schizophrenia
- Keywords
- Hippocampus, Neuromodulation, Sleep spindles, Thalamocortical circuits, Auditory stimulation, Magnetic resonance imaging, Sleep, Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Apr 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Experimental | Other: Closed loop auditory stimulation during sleepAdult outpatients with a diagnosis of schizophrenia. |
| Healthy Controls | Active comparator | Other: Closed loop auditory stimulation during sleepAdult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years old
- Fluent in English
- Able to give informed consent
- A DSM-V confirmed diagnosis of schizophrenia
- Unmedicated or maintained on a stable dose of APDs
Key exclusion criteria (13 listed)
- Ferrous metal in the body
- Currently pregnant or breastfeeding
- Motor problems that preclude finger tapping task
- IQ <85
- Other neurological disorders, including seizure disorder
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 |
|---|---|---|
| Closed loop auditory stimulation during sleepShort bursts of pink noise delivered at precise times during overnight sleep at home. | Other | Healthy Controls, Schizophrenia |
Primary outcome
Changes in sleep physiology
Time frame: across 5 nights of sleep with auditory stimulation
Changes in slow oscillations, sleep spindles, and slow oscillation-spindle coupled events as measured by sleep EEG headband
Changes in functional connectivity of the hippocampus and thalamus
Time frame: Approximately 1 week between baseline and follow-up scans
Changes in functional connectivity of the hippocampus and thalamus as measured by resting state functional connectivity MRI
Changes in hippocampal activation during motor sequence task (MST)
Time frame: Approximately 1 week between baseline and follow-up scans
Changes in hippocampal activation during the MST as measured by functional MRI
Changes in hippocampal microstructural integrity
Time frame: Approximately 30 minutes between pre- and post-task diffusion-weighted MRI scans
Changes in hippocampal microstructural integrity as measured by diffusion-weighted MRI
2 secondary outcomes
Greater gains in typing speed over rest breaks during MST training (micro-offline gains)
Time frame: Approximately 5 days between pre- and post-stimulation MST administrations
Sleep dependent memory consolidation (SDMC)
Time frame: Approximately 5 days between pre- and post-stimulation MST administrations
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop auditory stimulation during sleep in people with Schizophrenia, run by Massachusetts General Hospital 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 6 inclusion and 13 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 20 Oct 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 Lindsey Jones, MS (617-702-2368, manoachlab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep physiology (time frame: across 5 nights of sleep with auditory stimulation). 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 20 Oct 2026.