Alzheimer DiseaseNCT00183378
Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
A study testing Walking Program, Light Exposure Program and Combined Education, Walking and Light Exposure Program in people with Alzheimer Disease and Sleep Initiation and Maintenance Disorders, run by University of Washington at 1 site in United States.
Trial summary
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Walking Program, Light Exposure Program and Combined Education, Walking and Light Exposure Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable or possible Alzheimer's Disease
- Have at least two sleep disturbances, occurring 3 or more times per week
- Reside in a residential home with a family member caregiver
- Able to walk without assistance
- Currently caring for a family member with Alzheimer's disease
Who cannot join
- Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder
- Blindness
- Current use of photosensitizing medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's disease (AD).
Read the 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 minutes/day, 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.
- Being tested
- Walking Program, Light Exposure Program, Combined Education, Walking and Light Exposure Program, Routine Medical Care with Education
- Keywords
- Alzheimer's Disease, Insomnia, Sleep Problems, Elderly, Caregivers
- Medical subject headings
- Alzheimer Disease, Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking ProgramBehavioural
The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
Light Exposure ProgramBehavioural
The therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.
Combined Education, Walking and Light Exposure ProgramBehavioural
The therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
Routine Medical Care with EducationBehavioural
The therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Routine medical care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Receives: Behavioral: Routine Medical Care with Education |
| 2 | Active comparator | Walking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant. Receives: Behavioral: Walking Program |
| 3 | Active comparator | Light exposure: the therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour. Receives: Behavioral: Light Exposure Program |
| 4 | Active comparator | Combination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure. Receives: Behavioral: Combined Education, Walking and Light Exposure Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient total wake time (actigraphy)
Measured: Measured 3 times over 6 months
Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)
Measured: Measured 3 times over 6 months
Secondary outcomes (3)
Additional patient actigraphy outcomes
Measured: Measured 3 times over 6 months
Patient daytime sleepiness, behavioral problems, and residential status
Measured: Measured 3 times over 6 months
Caregiver sleep
Measured: Measured 3 times over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sue McCurry, University of Washington
- Investigators
- Susan M. McCurry, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183378
- Sponsor's protocol ID
- R01MH072736
- Other IDs
- R01MH072736, DATR A4-GPS
- Status last verified
- Jan 2012
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCurry SM, Gibbons LE, Logsdon RG, Vitiello M, Teri L. Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. J Am Geriatr Soc. 2003 Oct;51(10):1455-60. doi: 10.1046/j.1532-5415.2003.51466.x.
PubMed 14511168McCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Nighttime insomnia treatment and education for Alzheimer's disease: a randomized, controlled trial. J Am Geriatr Soc. 2005 May;53(5):793-802. doi: 10.1111/j.1532-5415.2005.53252.x.
PubMed 15877554McCurry SM, Pike KC, Logsdon RG, Vitiello MV, Larson EB, Teri L. Predictors of short- and long-term adherence to a daily walking program in persons with Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2010 Sep;25(6):505-12. doi: 10.1177/1533317510376173. Epub 2010 Jul 26.
PubMed 20660515McCurry SM, Pike KC, Vitiello MV, Logsdon RG, Larson EB, Teri L. Increasing walking and bright light exposure to improve sleep in community-dwelling persons with Alzheimer's disease: results of a randomized, controlled trial. J Am Geriatr Soc. 2011 Aug;59(8):1393-402. doi: 10.1111/j.1532-5415.2011.03519.x. Epub 2011 Jul 28.
PubMed 21797835
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00183378
- Acronym / sponsor ID
- R01MH072736
- Keywords
- Alzheimer's Disease, Insomnia, Sleep Problems, Elderly, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's 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 minutes/day, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Routine Medical Care with EducationRoutine medical care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. |
| 2 | Active comparator | Behavioral: Walking ProgramWalking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant. |
| 3 | Active comparator | Behavioral: Light Exposure ProgramLight exposure: the therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour. |
| 4 | Active comparator | Behavioral: Combined Education, Walking and Light Exposure ProgramCombination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of probable or possible Alzheimer's Disease
- Have at least two sleep disturbances, occurring 3 or more times per week
- Reside in a residential home with a family member caregiver
- Able to walk without assistance
- Currently caring for a family member with Alzheimer's disease
Key exclusion criteria (3 listed)
- Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder
- Blindness
- Current use of photosensitizing medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking ProgramThe therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant. | Behavioural | 2 |
| Light Exposure ProgramThe therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour. | Behavioural | 3 |
| Combined Education, Walking and Light Exposure ProgramThe therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure. | Behavioural | 4 |
| Routine Medical Care with EducationThe therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation. | Behavioural | 1 |
Primary outcome
Patient total wake time (actigraphy)
Time frame: Measured 3 times over 6 months
Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)
Time frame: Measured 3 times over 6 months
3 secondary outcomes
Additional patient actigraphy outcomes
Time frame: Measured 3 times over 6 months
Patient daytime sleepiness, behavioral problems, and residential status
Time frame: Measured 3 times over 6 months
Caregiver sleep
Time frame: Measured 3 times over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Background: PubMed 14511168McCurry SM, Gibbons LE, Logsdon RG, Vitiello M, Teri L. Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. J Am Geriatr Soc. 2003 Oct;51(10):1455-60. doi: 10.1046/j.1532-5415.2003.51466.x.
- Background: PubMed 15877554McCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Nighttime insomnia treatment and education for Alzheimer's disease: a randomized, controlled trial. J Am Geriatr Soc. 2005 May;53(5):793-802. doi: 10.1111/j.1532-5415.2005.53252.x.
- Results publication: PubMed 20660515McCurry SM, Pike KC, Logsdon RG, Vitiello MV, Larson EB, Teri L. Predictors of short- and long-term adherence to a daily walking program in persons with Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2010 Sep;25(6):505-12. doi: 10.1177/1533317510376173. Epub 2010 Jul 26.
- Results publication: PubMed 21797835McCurry SM, Pike KC, Vitiello MV, Logsdon RG, Larson EB, Teri L. Increasing walking and bright light exposure to improve sleep in community-dwelling persons with Alzheimer's disease: results of a randomized, controlled trial. J Am Geriatr Soc. 2011 Aug;59(8):1393-402. doi: 10.1111/j.1532-5415.2011.03519.x. Epub 2011 Jul 28.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M. McCurry, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Program, Light Exposure Program and Combined Education, Walking and Light Exposure Program in people with Alzheimer Disease and Sleep Initiation and Maintenance Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient total wake time (actigraphy) (time frame: Measured 3 times over 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183378, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.