Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218790
Status:
COMPLETED
Last Update Posted:
2014-02-12
First Post:
2005-09-16
Brief Title:
The Effects of Cool Dialysate on the SleepWake Cycle in Patients on Chronic Hemodialysis - The Sleep Cool Study
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Effects of Hemodialysis on the SleepWake Cycle
Status:
COMPLETED
Status Verified Date:
2005-09
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:
A major component of this study is to test a novel application for a safe non-pharmacologic cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleepwake cycle of chronic hemodialysis patients We will also evaluate its effects on selected sleep-related physiologic psychological behavioral and general health outcomes
Detailed Description:
Preliminary results demonstrate that after one treatment using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality Therefore a major component of this study is to test a novel application for a safe non-pharmacologic cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleepwake cycle of chronic hemodialysis patients We will also evaluate its effects on selected sleep-related physiologic psychological behavioral and general health outcomes
To test the efficacy of this intervention a randomized single-blinded pretest-posttest control group design is being used The major independent variable is dialysate temperature The major dependent variables are measures of sleep body temperature restactivity patterns and general health outcomes
To test the efficacy of this intervention a randomized single-blinded pretest-posttest control group design is being used The major independent variable is dialysate temperature The major dependent variables are measures of sleep body temperature restactivity patterns and general health outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| R01NR004340 | NIH | None | httpsreporternihgovquickSearchR01NR004340 |