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Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

Primary Purpose

Sleep, Alzheimer Disease, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep intervention
Placebo intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥65 years old
  • Memory complaints verified by an informant
  • Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
  • General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
  • No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Meets ICSD-2 criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping

Exclusion Criteria:

  • Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma
  • Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by DSM-IV), such as major depression, bipolar disorder, schizophrenia and other psychotic features
  • Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
  • History of alcohol or substance abuse within the past 2 years
  • Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association

Sites / Locations

  • UCSFRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sleep Intervention

Placebo intervention

Arm Description

Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)

Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration).

Outcomes

Primary Outcome Measures

Number of participants enrolled to the study
Number of participants that complete the study

Secondary Outcome Measures

Sleep as assessed by actigraphy
Week-long measurement using wrist actigraphy
Cognitive function assessed by standard neurocognitive battery

Full Information

First Posted
August 8, 2017
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03256539
Brief Title
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Official Title
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Intervention
Arm Type
Experimental
Arm Description
Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)
Arm Title
Placebo intervention
Arm Type
Placebo Comparator
Arm Description
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration).
Intervention Type
Behavioral
Intervention Name(s)
Sleep intervention
Intervention Description
Behavioral sleep intervention program
Intervention Type
Behavioral
Intervention Name(s)
Placebo intervention
Intervention Description
Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
Primary Outcome Measure Information:
Title
Number of participants enrolled to the study
Time Frame
Up to 24 weeks following study initiation
Title
Number of participants that complete the study
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Sleep as assessed by actigraphy
Description
Week-long measurement using wrist actigraphy
Time Frame
Through study completion, an average of 1 year
Title
Cognitive function assessed by standard neurocognitive battery
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥65 years old Memory complaints verified by an informant Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease Adequate visual and auditory acuity to allow neuropsychological testing Meets ICSD-2 criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping Exclusion Criteria: Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by DSM-IV), such as major depression, bipolar disorder, schizophrenia and other psychotic features Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol History of alcohol or substance abuse within the past 2 years Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Leng, PhD
Phone
4152214810
Ext
6565
Email
yue.leng@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Leng, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Landavazo, MA
Phone
415-340-2708
Email
bernard.landavazo@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

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