Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178204
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2005-09-12
Brief Title:
Sleep Architecture and Chemotherapy-Related Fatigue
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Sleep Architecture and Chemotherapy-Related Fatigue
Status:
COMPLETED
Status Verified Date:
2014-12
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 purpose of this study is to identify specific chemotherapy-related changes in sleep stagesarchitecture that may relate to an increase in fatigue in individuals with cancer
The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye movement cycles of sleep ie delta activity
The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye movement cycles of sleep ie delta activity
Detailed Description:
Studies have shown a strong positive correlation between self-reported changes in sleep and cancer patients fatigue and also between an objective measure of sleep continuity ie actigraphy and polysomnography PSG and self-reported fatigue Chemotherapy disrupts normal sleep patterns and fatigue in the later stages of chemotherapy may occur as a result of disturbed nocturnal sleep continuity However the causes of chemotherapy-related fatigue remain unknown and whether or not abnormal sleep architecture contributes to this debilitating effect has yet to be explored We believe that fatigue experienced by many cancer patients receiving chemotherapy is due at least in part to changes in delta activity ie restorative sleep during the non-rapid eye movement NREM cycles of sleep A finding that slow wave sleep abnormalities play a significant role in fatigue would prompt further confirmatory studies and support controlled intervention studies
Comparisons In a clinical trial of individuals with cancer prior to during and after completion of chemotherapy we will identify and compare specific chemotherapy-related changes in sleep stagesarchitecture that may relate to an increase in fatigue These changes will be measured by actigraphy PSG and patient self-reporting techniques eg sleep diaries questionnaires
The primary objective is to
examine the role of delta sleep in the development of chemotherapy-induced fatigue in cancer patients
Secondary objectives are to
characterize the involvement of other elements of sleep architecture eg rapid eye movement REM sleep and changes in sleep continuity relating to the development of chemotherapy-induced fatigue in cancer patients
examine the role of sleep architecture in the persistence of chemotherapy-induced fatigue
examine in post hoc analyses the relationship of various physical symptoms and patient variables that may be related to fatigue eg pain hot flashes anxiety hemoglobin menopausal status sleep continuity and QOL and to each other both during and following chemotherapy
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue
Comparisons In a clinical trial of individuals with cancer prior to during and after completion of chemotherapy we will identify and compare specific chemotherapy-related changes in sleep stagesarchitecture that may relate to an increase in fatigue These changes will be measured by actigraphy PSG and patient self-reporting techniques eg sleep diaries questionnaires
The primary objective is to
examine the role of delta sleep in the development of chemotherapy-induced fatigue in cancer patients
Secondary objectives are to
characterize the involvement of other elements of sleep architecture eg rapid eye movement REM sleep and changes in sleep continuity relating to the development of chemotherapy-induced fatigue in cancer patients
examine the role of sleep architecture in the persistence of chemotherapy-induced fatigue
examine in post hoc analyses the relationship of various physical symptoms and patient variables that may be related to fatigue eg pain hot flashes anxiety hemoglobin menopausal status sleep continuity and QOL and to each other both during and following chemotherapy
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue
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