Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256503
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2005-11-16
Brief Title:
Sleep Homeostasis in Primary Insomnia
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment
Status:
COMPLETED
Status Verified Date:
2016-01
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:
About 10 of the population is believed to suffer from Primary Insomnia It is also believed that people with chronic insomnia have a sleep system that is essentially out of alignment we call this homeostatic dysregulation We also know that a certain form of non-medication therapy called cognitive-behavioral therapy is a very effective treatment for insomnia It is not known however whether cognitive-behavioral therapy actually works by bringing the brains sleep system back into alignment sleep homeostasis One of the methods used to measure sleep homeostasis is to observe a persons brain waves during sleep and particularly during sleep that follows a period of sleep loss
The purposes of this study are to first learn whether persons with insomnia do have a misaligned sleep system compared to persons who do not have insomnia by assessing the sleep of people before and after a period of extended sleep loss Second the study will determine whether cognitive-behavioral therapy can re-regulate the sleep system and its response to sleep loss Third the final purpose is to examine whether the immune system of people with insomnia is more altered following sleep loss than in the comparison group and whether cognitive-behavioral therapy can alter immune function
The purposes of this study are to first learn whether persons with insomnia do have a misaligned sleep system compared to persons who do not have insomnia by assessing the sleep of people before and after a period of extended sleep loss Second the study will determine whether cognitive-behavioral therapy can re-regulate the sleep system and its response to sleep loss Third the final purpose is to examine whether the immune system of people with insomnia is more altered following sleep loss than in the comparison group and whether cognitive-behavioral therapy can alter immune function
Detailed Description:
Despite the magnitude of the problem of Primary Insomnia and the good efficacy of Cognitive Behavioral Treatment for Insomnia CBT-I little is known about the pathophysiology of insomnia or whether treatment alters the factors that are thought to maintain chronic insomnia Three main factors have been explored as contributing to chronic insomnia hyperarousal circadian dysrhythmia and homeostatic dysregulation Most of the empirical work has been related to the role of hyperarousal along three dimensions somatic cognitive and cortical
The present study is focused on homeostatic abnormalities and secondarily on hyperarousal as exhibited in subjects with Primary Insomnia PIs compared to Good Sleeper controls GSs Homeostatic abnormalities will be assessed by evaluating how patients with insomnia respond to sleep deprivation
This study will use a Modified Sleep Deprivation and Multiple Sleep Latency Test MSDMSLT procedure Response to the procedure will be assessed in terms of sleep continuity sleep architecture and electroencephalographic EEG power spectral changes during recovery sleep Hyperarousal will be evaluated using serial measures of somatic cortisol and cortical EEG BetaGamma activity arousal across the sleep deprivation protocol
These parameters will be evaluated both prior to and following CBT-I in PIs and following an equivalent time interval in GSs
The present study is focused on homeostatic abnormalities and secondarily on hyperarousal as exhibited in subjects with Primary Insomnia PIs compared to Good Sleeper controls GSs Homeostatic abnormalities will be assessed by evaluating how patients with insomnia respond to sleep deprivation
This study will use a Modified Sleep Deprivation and Multiple Sleep Latency Test MSDMSLT procedure Response to the procedure will be assessed in terms of sleep continuity sleep architecture and electroencephalographic EEG power spectral changes during recovery sleep Hyperarousal will be evaluated using serial measures of somatic cortisol and cortical EEG BetaGamma activity arousal across the sleep deprivation protocol
These parameters will be evaluated both prior to and following CBT-I in PIs and following an equivalent time interval in GSs
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 |
|---|---|---|---|
| 012331 | OTHER_GRANT | American Sleep Medicine Foundation | None |