Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183378
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
2005-09-13
Brief Title:
Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimers Disease
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Behavioral Treatment of Nocturnal Disturbances in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2012-01
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:
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimers disease AD
Detailed Description:
Nocturnal disturbances such as getting out of bed repeatedly having hallucinations talking or singing in bed and waking up confused are common among patients with AD Such nocturnal disturbances are associated with increased physical and psychological morbidity in both AD patients and their caregivers and are a major risk factor for patient institutionalization Nonpharmacologic treatments for these disturbances are needed This study will assign AD patients to one of four different treatments to determine which is most effective in reducing nocturnal disturbances
This study will last 6 months Participants will be randomly assigned to a walking program a light exposure program a NITE-AD program combining the walking and light exposure programs or routine AD care with nocturnal disturbance education Walking program participants will have three 1-hour visits with a therapist over an 8-week period The therapist and the participant will set an initial daily walking goal and develop a plan for gradually increasing the participants walking to 30 minutesday to be increased at a participant-selected pace Pedometers will be given to participants to monitor daily activity The therapist will also discuss exercise safety and will review ways to prevent muscle soreness Light program participants will also have three 1-hour visits with a therapist over 8 weeks The therapist will develop a daily caregiver-supervised light exposure plan requiring participants to sit in front of a light box for 1 hour every day NITE-AD program participants will have six 1-hour visits with a therapist over 8 weeks their visits will include setting up both walking and the light exposure routines Participants assigned to education will receive information about about sleep in aging and dementia but no assistance setting up walking or light exposure plans
Participants will be assessed at study entry and at Months 2 post-test and 6 The sleep patterns of both the patients and the caregivers will be measured Caregiver reports of patients night-time behavioral disturbances and readings from an actigraph a small electronic device worn by participants that records and reports their levels of activity at night will be used to estimate sleep The study will also collect data on patient and caregiver mood stress and behavior A follow-up visit will occur 6 months after study completion at the follow-up visit the same outcome measures will be collected as at baseline and post-test Participants will receive 3 biannual phone follow-ups 12 18 and 24 months to assess patient residential status and caregiver reports of patient and caregiver sleep
This study will last 6 months Participants will be randomly assigned to a walking program a light exposure program a NITE-AD program combining the walking and light exposure programs or routine AD care with nocturnal disturbance education Walking program participants will have three 1-hour visits with a therapist over an 8-week period The therapist and the participant will set an initial daily walking goal and develop a plan for gradually increasing the participants walking to 30 minutesday to be increased at a participant-selected pace Pedometers will be given to participants to monitor daily activity The therapist will also discuss exercise safety and will review ways to prevent muscle soreness Light program participants will also have three 1-hour visits with a therapist over 8 weeks The therapist will develop a daily caregiver-supervised light exposure plan requiring participants to sit in front of a light box for 1 hour every day NITE-AD program participants will have six 1-hour visits with a therapist over 8 weeks their visits will include setting up both walking and the light exposure routines Participants assigned to education will receive information about about sleep in aging and dementia but no assistance setting up walking or light exposure plans
Participants will be assessed at study entry and at Months 2 post-test and 6 The sleep patterns of both the patients and the caregivers will be measured Caregiver reports of patients night-time behavioral disturbances and readings from an actigraph a small electronic device worn by participants that records and reports their levels of activity at night will be used to estimate sleep The study will also collect data on patient and caregiver mood stress and behavior A follow-up visit will occur 6 months after study completion at the follow-up visit the same outcome measures will be collected as at baseline and post-test Participants will receive 3 biannual phone follow-ups 12 18 and 24 months to assess patient residential status and caregiver reports of patient and caregiver sleep
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 |
|---|---|---|---|
| DATR A4-GPS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH072736 |
| R01MH072736 | NIH | None | None |