SleepCLASS-DNCT04206059

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

A study testing MRI, Quantitative Sensory Testing (QST) and Home sleep study in people with Sleep and Sedation Complication, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves. Anti-phase stimulation will serve as an active control while sham stimulation will serve as a passive control. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Sleep, Sedation Complication
What is being tested?: MRI, Quantitative Sensory Testing (QST) and Home sleep study
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2021to 1 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 18-40 years
Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).

Who cannot join

Diagnosed sleep disorders
Habitually short sleepers
Diagnosed psychiatric disorders
Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
Neck circumference > 40 cm
Body Mass Index > 30

Show all 10Show fewer

Acknowledged recreational drug or nicotine use
Resting heart rate during slow wave sleep < 40 beats per minute
Pregnancy or nursing
Persistently inconsistent or elevated QST heat pain tolerance thresholds (>50 ºC).

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Read the detailed description

Both nonpharmacologic and pharmacologic interventions augment expression of EEG slow waves that mimic those of natural sleep. Closed loop auditory stimulation (CLAS) is a noninvasive inexpensive approach to augment the spectral power and duration of these slow waves. Whether in-phase CLAS may address this need is unknown, since acoustic potentiation of pharmacologically-induced slow waves has not been investigated. This prospective within-subject study of dexmedetomidine sedation paired with CLAS will assess the feasibility of augmenting EEG slow waves during sedation.

Conditions: Sleep, Sedation Complication
Being tested: MRI, Quantitative Sensory Testing (QST), Home sleep study, Acoustic stimulation (65 decibels or db) up-slope of EEG with QST, Acoustic stimulation (65db) down-slope of EEG with QST

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRIRadiation
Also called Structural magnetic resonance imaging
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Quantitative Sensory Testing (QST)Diagnostic test
Also called Quantitative Sensory Testing
Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
Home sleep studyDiagnostic test
Also called Unattended polysomnography
Unattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.
Acoustic stimulation (65 decibels or db) up-slope of EEG with QSTOther
Also called In-phase CLAS with sensory testing
Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
Acoustic stimulation (65db) down-slope of EEG with QSTOther
Also called Anti-phase CLAS with sensory testing
65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
0 db with QSTOther
Also called Sham CLAS with sensory testing
sham stimulation (0 dB volume)
DexmedetomidineDrug
Also called Dexmedetomidine hydrochloride
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
Breathe-Squeeze TaskOther
Also called Internally directed behavioral task
All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.

Study groups in NCT04206059
Study group	Role	What they receive
CLASS-D Cohort - In-phase	Experimental	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation Receives: Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: Acoustic stimulation (65 decibels or db) up-slope of EEG with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task
CLASS-D Cohort - Anti-phase	Active comparator	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation Receives: Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: Acoustic stimulation (65db) down-slope of EEG with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task
CLASS-D Cohort - Sham	Sham comparator	Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered. Receives: Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: 0 db with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Measured: Sham stimulation and in-phase stimulation blocks during the intervention
Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Measured: Anti-phase and in-phase blocks during the intervention
Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation
Difference in EEG slow wave density from anti-phase to in-phase stimulation by looking at EEG slow waves duration relative to the timing of the stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Measured: anti-phase and in-phase blocks during the intervention
Difference in EEG Slow Wave Density From Sham to In-phase Stimulation
Difference in EEG slow wave density from sham to in-phase stimulation by looking at EEG slow waves relative to the timing of the stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Measured: Sham stimulation and in-phase stimulation blocks during the intervention

Secondary outcomes (3)

Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation
Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Measured: Anti-phase and in-phase blocks of the intervention
Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation
Difference of reactivity to thermal stimulation from sham to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Measured: Sham and in-phase blocks during intervention
Slow Wave Activity Calculated During N3 Sleep
Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session. Calculated as power
Measured: on the nights before and the night of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20211 Jul 2023

First posted20 Dec 2019
Study start20 Jan 2021
Primary completion1 Jun 2022
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for SleepStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04206059
Sponsor's protocol ID: 201907086
Acronym: CLASS-D
Status last verified: Apr 2026
First submitted: 9 Dec 2019
Last updated: 1 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Prerau MJ, Brown RE, Bianchi MT, Ellenbogen JM, Purdon PL. Sleep Neurophysiological Dynamics Through the Lens of Multitaper Spectral Analysis. Physiology (Bethesda). 2017 Jan;32(1):60-92. doi: 10.1152/physiol.00062.2015.
PubMed 27927806
Leger D, Debellemaniere E, Rabat A, Bayon V, Benchenane K, Chennaoui M. Slow-wave sleep: From the cell to the clinic. Sleep Med Rev. 2018 Oct;41:113-132. doi: 10.1016/j.smrv.2018.01.008. Epub 2018 Feb 5.
PubMed 29490885
Neske GT. The Slow Oscillation in Cortical and Thalamic Networks: Mechanisms and Functions. Front Neural Circuits. 2016 Jan 14;9:88. doi: 10.3389/fncir.2015.00088. eCollection 2015.
PubMed 26834569
Smith SK, Kafashan M, Rios RL, Brown EN, Landsness EC, Guay CS, Palanca BJA. Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults. BJA Open. 2024 Mar 28;10:100276. doi: 10.1016/j.bjao.2024.100276. eCollection 2024 Jun.
PubMed 38571816
Guay CS, Hight D, Gupta G, Kafashan M, Luong AH, Avidan MS, Brown EN, Palanca BJA. Breathe-squeeze: pharmacodynamics of a stimulus-free behavioural paradigm to track conscious states during sedation☆. Br J Anaesth. 2023 May;130(5):557-566. doi: 10.1016/j.bja.2023.01.021. Epub 2023 Mar 24.
PubMed 36967282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
ClinicalTrials.gov ID: NCT04206059
Acronym / sponsor ID: CLASS-D / 201907086
Conditions: Sleep, Sedation Complication
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 20 Jan 2021 (actual)
Primary completion: 1 Jun 2022 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 20 Dec 2019 (actual)
Results: Posted 1 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CLASS-D Cohort - In-phase	Experimental	Radiation: MRI, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Home sleep study, Other: Acoustic stimulation (65 decibels or db) up-slope of EEG with QST, Drug: Dexmedetomidine, Other: Breathe-Squeeze TaskWithin-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
CLASS-D Cohort - Anti-phase	Active comparator	Radiation: MRI, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Home sleep study, Other: Acoustic stimulation (65db) down-slope of EEG with QST, Drug: Dexmedetomidine, Other: Breathe-Squeeze TaskWithin-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
CLASS-D Cohort - Sham	Sham comparator	Radiation: MRI, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Home sleep study, Other: 0 db with QST, Drug: Dexmedetomidine, Other: Breathe-Squeeze TaskWithin-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Age 18-40 years
Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).

Key exclusion criteria (10 listed)

Diagnosed sleep disorders
Habitually short sleepers
Diagnosed psychiatric disorders
Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
Neck circumference > 40 cm

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
MRIAlso: Structural magnetic resonance imagingA non-contrast brain MRI will be acquired for localizing EEG slow waves	Radiation	CLASS-D Cohort - Anti-phase, CLASS-D Cohort - In-phase, CLASS-D Cohort - Sham
Quantitative Sensory Testing (QST)Also: Quantitative Sensory TestingQuantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.	Diagnostic test	CLASS-D Cohort - Anti-phase, CLASS-D Cohort - In-phase, CLASS-D Cohort - Sham
Home sleep studyAlso: Unattended polysomnographyUnattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.	Diagnostic test	CLASS-D Cohort - Anti-phase, CLASS-D Cohort - In-phase, CLASS-D Cohort - Sham
Acoustic stimulation (65 decibels or db) up-slope of EEG with QSTAlso: In-phase CLAS with sensory testingAcoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves	Other	CLASS-D Cohort - In-phase
Acoustic stimulation (65db) down-slope of EEG with QSTAlso: Anti-phase CLAS with sensory testing65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)	Other	CLASS-D Cohort - Anti-phase
0 db with QSTAlso: Sham CLAS with sensory testingsham stimulation (0 dB volume)	Other	CLASS-D Cohort - Sham
DexmedetomidineAlso: Dexmedetomidine hydrochlorideAll participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml	Drug	CLASS-D Cohort - Anti-phase, CLASS-D Cohort - In-phase, CLASS-D Cohort - Sham
Breathe-Squeeze TaskAlso: Internally directed behavioral taskAll participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.	Other	CLASS-D Cohort - Anti-phase, CLASS-D Cohort - In-phase, CLASS-D Cohort - Sham

Primary outcome

Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation
Time frame: Sham stimulation and in-phase stimulation blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation
Time frame: Anti-phase and in-phase blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation
Time frame: anti-phase and in-phase blocks during the intervention
Difference in EEG slow wave density from anti-phase to in-phase stimulation by looking at EEG slow waves duration relative to the timing of the stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Difference in EEG Slow Wave Density From Sham to In-phase Stimulation
Time frame: Sham stimulation and in-phase stimulation blocks during the intervention
Difference in EEG slow wave density from sham to in-phase stimulation by looking at EEG slow waves relative to the timing of the stimulation All participants serve in the same arm but experience both sham and in-phase blocks.

3 secondary outcomes

Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation
Time frame: Anti-phase and in-phase blocks of the intervention
Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation
Time frame: Sham and in-phase blocks during intervention
Slow Wave Activity Calculated During N3 Sleep
Time frame: on the nights before and the night of the intervention

Results and safety

Results posted to the registry on 1 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CLASS-D Cohort	16	16

Primary outcome: Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation

Time frame: Sham stimulation and in-phase stimulation blocks during the intervention. Median (Full Range). Unit: Log(μV squared)

Measure	CLASS-D Cohort - Sham n = 14	CLASS-D Cohort In-phase n = 14
Value	1.592 (1.093 to 2.017)	1.694 (1.162 to 2.217)

Primary outcome: Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation

Time frame: Anti-phase and in-phase blocks during the intervention. Median (Full Range). Unit: log(μV squared)

Measure	CLASS-D Cohort - Anti-phase n = 14	CLASS-D Cohort - In-phase n = 14
Value	1.511 (1.014 to 1.885)	1.694 (1.162 to 2.217)

Primary outcome: Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation

Time frame: anti-phase and in-phase blocks during the intervention. Median (Full Range). Unit: waves/minute

Measure	CLASS-D Cohort - In-phase n = 12	CLASS-D Cohort - Anti-phase n = 12
Value	6.9 (0 to 24)	6 (0 to 18.9)

Primary outcome: Difference in EEG Slow Wave Density From Sham to In-phase Stimulation

Time frame: Sham stimulation and in-phase stimulation blocks during the intervention. Median (Full Range). Unit: waves/minute

Measure	CLASS-D Cohort - In-phase n = 12	CLASS-D Cohort - Sham n = 12
Value	6 (0 to 24)	4.3 (0 to 26.5)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLASS-D Cohort While Performing Task Without Sedation	0 of 16 (0%)	0 of 16 (0%)	0 of 16
CLASS-D Cohort While Performing Task With Sedation	0 of 16 (0%)	0 of 16 (0%)	0 of 16
CLASS-D Cohort Unresponsive During Sedation But Before CLAS	0 of 16 (0%)	4 of 16 (25%)	0 of 16
CLASS-D Cohort - In-phase After Becoming Unresponsive to Task	0 of 16 (0%)	0 of 16 (0%)	0 of 16
CLASS-D Cohort - Anti-phase After Becoming Unresponsive to Task	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Sham Comparator: CLASS-D Cohort - Sham After Becoming Unresponsive to Task	0 of 16 (0%)	0 of 16 (0%)	0 of 16
CLASS-D Cohort Unresponsive During Sedation and After CLAS	0 of 16 (0%)	0 of 16 (0%)	0 of 16
CLASS-D Cohort Awake Performing Task While Recovering From Sedation	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27927806Prerau MJ, Brown RE, Bianchi MT, Ellenbogen JM, Purdon PL. Sleep Neurophysiological Dynamics Through the Lens of Multitaper Spectral Analysis. Physiology (Bethesda). 2017 Jan;32(1):60-92. doi: 10.1152/physiol.00062.2015.
Background: PubMed 29490885Leger D, Debellemaniere E, Rabat A, Bayon V, Benchenane K, Chennaoui M. Slow-wave sleep: From the cell to the clinic. Sleep Med Rev. 2018 Oct;41:113-132. doi: 10.1016/j.smrv.2018.01.008. Epub 2018 Feb 5.
Background: PubMed 26834569Neske GT. The Slow Oscillation in Cortical and Thalamic Networks: Mechanisms and Functions. Front Neural Circuits. 2016 Jan 14;9:88. doi: 10.3389/fncir.2015.00088. eCollection 2015.
Derived from this study: PubMed 38571816Smith SK, Kafashan M, Rios RL, Brown EN, Landsness EC, Guay CS, Palanca BJA. Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults. BJA Open. 2024 Mar 28;10:100276. doi: 10.1016/j.bjao.2024.100276. eCollection 2024 Jun.
Derived from this study: PubMed 36967282Guay CS, Hight D, Gupta G, Kafashan M, Luong AH, Avidan MS, Brown EN, Palanca BJA. Breathe-squeeze: pharmacodynamics of a stimulus-free behavioural paradigm to track conscious states during sedation☆. Br J Anaesth. 2023 May;130(5):557-566. doi: 10.1016/j.bja.2023.01.021. Epub 2023 Mar 24.

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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.

Ben J Palanca, MD PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 10 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: finished, as of the sponsor's last update on 1 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation (time frame: Sham stimulation and in-phase stimulation blocks during the intervention). 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?

On the ClinicalTrials.gov record for NCT04206059, which also lists 5 linked publications.

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 1 May 2026.