Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471374
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-18
Brief Title:
Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
Sponsor:
University of Colorado Boulder
Organization:
University of Colorado Boulder
Study Overview
Official Title:
Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this study is to understand factors that contribute to delayed sleep wake phase disorder DSWPD The investigators will examine whether patients with DSWPD exhibit alterations in circadian rhythms and sensitivity to light compared to healthy controls The investigators will also test a new method of predicting circadian rhythms form a blood sample
Detailed Description:
The research parts of the study are 65 weeks long and the study including screening visits involves 6 in-person visits to the Boulder campus
If participants qualify for the study and choose to participate there will be two visits where participants will pick up research equipment to wear at home for 1-2 weeks of ambulatory monitoring before being studied in the laboratory The first ambulatory monitoring session is for 2 weeks and the second is one week
On the first ambulatory monitoring session the investigators will have participants answer questions about participants mood and cognition
On both ambulatory monitoring sessions the investigators will also ask participants to wear a blood sugar monitor and track the timing of when participants eat using a phone app The investigators will also have participants wear a wrist worn sleep and light monitor plus a daily sleep log and Google form of when participants go to bed and wake up
Next will be a visit where participants will spend 66 hours 275 days in the laboratory
While living in the lab participants will not be aware of the time of day eg no clocks internet cell phones and the investigators will schedule participants activities
The investigators will ask participants to remain seated in bed and awake for up to 39 hours with the head of the bed raised Participants will be studied under dim light similar to candlelight
The investigators will frequently take saliva samples for more than 24 hours when the investigators will ask participants to stay awake The investigators will also take four blood samples
The investigators will also ask participants to perform reaction time tests tests of participants ability to think and to complete ratings of how participants feel multiple times each day that participants are in the lab
The investigators will also record participants brain wave activity muscle activity eye movements and heart rate when participants stay awake and during 9h sleep opportunities
The investigators will then ask participants to sleep normally at home for 2 weeks followed by 1 week of ambulatory monitoring
Finally there will be a visit where participants will spend 48 hours 2 days in the laboratory
While living in the lab participants will not be aware of the time of day eg no clocks internet cell phones and the investigators will schedule participants activities
The investigators will expose participants to different light levels dim light similar to candlelight and typical room light
The investigators will frequently take saliva samples
The investigators will also ask participants to perform reaction time tests tests of participants ability to think and to complete ratings of how participants feel multiple times each day that participants are in the lab
The investigators will also record participants brain wave activity muscle activity eye movements and heart rate when participants are awake and while participants sleep
If participants qualify for the study and choose to participate there will be two visits where participants will pick up research equipment to wear at home for 1-2 weeks of ambulatory monitoring before being studied in the laboratory The first ambulatory monitoring session is for 2 weeks and the second is one week
On the first ambulatory monitoring session the investigators will have participants answer questions about participants mood and cognition
On both ambulatory monitoring sessions the investigators will also ask participants to wear a blood sugar monitor and track the timing of when participants eat using a phone app The investigators will also have participants wear a wrist worn sleep and light monitor plus a daily sleep log and Google form of when participants go to bed and wake up
Next will be a visit where participants will spend 66 hours 275 days in the laboratory
While living in the lab participants will not be aware of the time of day eg no clocks internet cell phones and the investigators will schedule participants activities
The investigators will ask participants to remain seated in bed and awake for up to 39 hours with the head of the bed raised Participants will be studied under dim light similar to candlelight
The investigators will frequently take saliva samples for more than 24 hours when the investigators will ask participants to stay awake The investigators will also take four blood samples
The investigators will also ask participants to perform reaction time tests tests of participants ability to think and to complete ratings of how participants feel multiple times each day that participants are in the lab
The investigators will also record participants brain wave activity muscle activity eye movements and heart rate when participants stay awake and during 9h sleep opportunities
The investigators will then ask participants to sleep normally at home for 2 weeks followed by 1 week of ambulatory monitoring
Finally there will be a visit where participants will spend 48 hours 2 days in the laboratory
While living in the lab participants will not be aware of the time of day eg no clocks internet cell phones and the investigators will schedule participants activities
The investigators will expose participants to different light levels dim light similar to candlelight and typical room light
The investigators will frequently take saliva samples
The investigators will also ask participants to perform reaction time tests tests of participants ability to think and to complete ratings of how participants feel multiple times each day that participants are in the lab
The investigators will also record participants brain wave activity muscle activity eye movements and heart rate when participants are awake and while participants sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL159647-01 | NIH | None | None |