Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04680910
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2020-12-17
Brief Title:
Slow Wave Induction by Propofol to Eliminate Depression SWIPED
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Precision Targeting of Propofol-induced Electroencephalographic Slow Waves a Novel Phase I2 Paradigm for Treatment-resistant Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our hypothesis is that targeted propofol infusion in TRD patients will induce slow wave activity during sedation and augment subsequent sleep slow wave activity We will recruit 15 participants for this open label single arm Phase I trial All participants will undergo two propofol infusions 2-6 days apart with each infusion maximizing expression of EEG slow waves To minimize bias there will be no specific gender or ethnic background consideration for enrollment This will be a single site investigation at Washington University Medical Center
Detailed Description:
Treatment-resistant depression TRD in older adults is a leading cause of disability excess mortality from suicide and dementia Cognitive problems and sleep disturbances are common contributing to recurrence and poor long-term outcomes Disrupted slow wave sleep is at the nexus of depression and cognitive dysfunction in older adults Novel approaches to target this core pathophysiology are lacking Our mechanistic project is designed to elucidate the relationships between TRD and sleep disturbances in older adults Through personalized infusions targeting electroencephalographic EEG patterns we aim for a systematic characterization of the relationships between the propofol-induced EEG slow waves and enhancement of slow wave sleep Through the repurposing of propofol as a therapeutic probe this innovative proposal will establish whether EEG slow waves are a viable therapeutic target for novel antidepressant approaches
Study Intervention
Propofol will be infused through a peripheral IV with the assistance of target-controlled infusion software and pumps with an anticipated infusion duration of 1-2 hours Concurrent high-density EEG will be acquired but with an updated recording rig and sensor nets that use either Elefix conductive gel or salt solution An Axis P3364LV network camera synchronized to EEG recordings will provide video for post-hoc analysis Participants will be discharged home after nurse monitoring and fulfillment of post-anesthetic care unit criteria
Patients will be instructed by staff on operation of the Dreem headband for at-home overnight sleep EEG recordings Patients will demonstrate ability to successfully wear the Dreem and initiate recordings without assistance The device charger instruction sheet and a link to a 2-minute instructional video will be provided to patients This paradigm has been successful in the acquisition of preoperative sleep recordings in over 150 geriatric cardiac surgical patients and eight patients who underwent ECT for TRD ClinicalTrialsgov NCT04451135
Dreem recordings will be obtained prior to the first propofol infusion and on evenings of propofol infusions Additionally recordings will be obtained for up to 6 nights within a 2-week period after the final infusion to evaluate persistence of restoration of sleep architecture Participants will exchange the device with staff during each in-person visit to allow device examination and data download
Planned subgroup analyses include stratification by sex and age For the purposes of Phase II of the study additional subgroup analyses will be performed based on baseline sleep structure eg total sleep time and proportion of time in N3 sleep and time interval separating the two infusions
Study Intervention
Propofol will be infused through a peripheral IV with the assistance of target-controlled infusion software and pumps with an anticipated infusion duration of 1-2 hours Concurrent high-density EEG will be acquired but with an updated recording rig and sensor nets that use either Elefix conductive gel or salt solution An Axis P3364LV network camera synchronized to EEG recordings will provide video for post-hoc analysis Participants will be discharged home after nurse monitoring and fulfillment of post-anesthetic care unit criteria
Patients will be instructed by staff on operation of the Dreem headband for at-home overnight sleep EEG recordings Patients will demonstrate ability to successfully wear the Dreem and initiate recordings without assistance The device charger instruction sheet and a link to a 2-minute instructional video will be provided to patients This paradigm has been successful in the acquisition of preoperative sleep recordings in over 150 geriatric cardiac surgical patients and eight patients who underwent ECT for TRD ClinicalTrialsgov NCT04451135
Dreem recordings will be obtained prior to the first propofol infusion and on evenings of propofol infusions Additionally recordings will be obtained for up to 6 nights within a 2-week period after the final infusion to evaluate persistence of restoration of sleep architecture Participants will exchange the device with staff during each in-person visit to allow device examination and data download
Planned subgroup analyses include stratification by sex and age For the purposes of Phase II of the study additional subgroup analyses will be performed based on baseline sleep structure eg total sleep time and proportion of time in N3 sleep and time interval separating the two infusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01MH128483 | NIH | None | httpsreporternihgovquickSearchU01MH128483 |