SchizophreniaNCT04783571
Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
A study testing Auditory Stimulation in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Auditory Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For healthy controls:
- Male and female subjects
- 18-50 years of age
- Proficient in English
- For schizophrenia patients:
- Male and female schizophrenia outpatients
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- 18-50 years of age
- Proficient in English
- Able to give informed consent
Who cannot join
- Pregnant females
- Current use of psychotropic medications (healthy controls only)
- A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
- IQ <85
- Neurological disorder (including seizure disorder)
- Significant hearing or vision loss
Show all 9Show fewer
- Current substance abuse or dependence (nicotine abuse or dependence is not exclusionary)
- Any unstable chronic medical condition that affects sleep
- Diagnosed sleep disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Placebo, Auditory Stimulation
- Keywords
- sleep, memory, schizophrenia, auditory stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Auditory stimulation will not be delivered during the nap
Auditory StimulationOther
Auditory stimulation will be delivered during the nap
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Experimental | Adult outpatients with a diagnosis of schizophrenia. Receives: Other: Placebo; Other: Auditory Stimulation |
| Healthy Controls | Experimental | Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Receives: Other: Placebo; Other: Auditory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in slow-oscillation spindle coupling
Differences in slow oscillation-spindle coupling during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Measured: Placebo and auditory stimulation naps will be approximately one week apart
Secondary outcomes (3)
Differences in sleep-dependent consolidation of motor procedural memory
Differences in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between placebo and auditory stimulation naps. The MST involves pressing four numerically labeled keys on a standard keypad, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences are employed for the placebo and stimulation visits in a counter-balanced order.
Measured: Placebo and auditory stimulation naps will be approximately one week apart
Differences in slow oscillations
Differences in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Measured: Placebo and auditory stimulation naps will be approximately one week apart
Differences in sleep spindles
Differences in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
Measured: Placebo and auditory stimulation naps will be approximately one week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start13 Apr 2020
- Primary completion31 Dec 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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
- Investigators
- Dara Manoach, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783571
- Sponsor's protocol ID
- 2018P002573
- Status last verified
- May 2026
- First submitted
- 19 Feb 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD data.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
- ClinicalTrials.gov ID
- NCT04783571
- Acronym / sponsor ID
- 2018P002573
- Conditions
- Schizophrenia
- Keywords
- sleep, memory, schizophrenia, auditory stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2021 (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 investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Experimental | Other: Placebo, Other: Auditory StimulationAdult outpatients with a diagnosis of schizophrenia. |
| Healthy Controls | Experimental | Other: Placebo, Other: Auditory StimulationAdult 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 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects
- 18-50 years of age
- Proficient in English
- Male and female schizophrenia outpatients
- 18-50 years of age
Key exclusion criteria (9 listed)
- Pregnant females
- Current use of psychotropic medications (healthy controls only)
- A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
- IQ <85
- Neurological disorder (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 |
|---|---|---|
| PlaceboAuditory stimulation will not be delivered during the nap | Other | Healthy Controls, Schizophrenia |
| Auditory StimulationAuditory stimulation will be delivered during the nap | Other | Healthy Controls, Schizophrenia |
Primary outcome
Differences in slow-oscillation spindle coupling
Time frame: Placebo and auditory stimulation naps will be approximately one week apart
Differences in slow oscillation-spindle coupling during non-rapid eye movement (NREM) sleep as measured by EEG between placebo and auditory stimulation naps
3 secondary outcomes
Differences in sleep-dependent consolidation of motor procedural memory
Time frame: Placebo and auditory stimulation naps will be approximately one week apart
Differences in slow oscillations
Time frame: Placebo and auditory stimulation naps will be approximately one week apart
Differences in sleep spindles
Time frame: Placebo and auditory stimulation naps will be approximately one week apart
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 13 May 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD data.
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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.
Dara Manoach, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Stimulation 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 13 May 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?
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?
Differences in slow-oscillation spindle coupling (time frame: Placebo and auditory stimulation naps will be approximately one week apart). 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 13 May 2026.