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

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ClinicalTrials.gov Identifier: NCT03256539
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 8, 2017
First Posted Date  ICMJE August 22, 2017
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE August 12, 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • Number of participants enrolled to the study [ Time Frame: Up to 24 weeks following study initiation ]
  • Number of participants that complete the study [ Time Frame: Through study completion, an average of 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • Sleep as assessed by actigraphy [ Time Frame: Through study completion, an average of 1 year ]
    Week-long measurement using wrist actigraphy
  • Cognitive function assessed by standard neurocognitive battery [ Time Frame: Through study completion, an average of 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
Official Title  ICMJE Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Sleep
  • Alzheimer Disease
  • Cognitive Impairment
  • Aging
  • CBT
Intervention  ICMJE
  • Behavioral: Sleep intervention
    Behavioral sleep intervention program
  • Behavioral: Placebo intervention
    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)
Study Arms  ICMJE
  • Experimental: Sleep Intervention
    Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)
    Intervention: Behavioral: Sleep intervention
  • Placebo Comparator: Placebo intervention
    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: Behavioral: Placebo intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yue Leng, PhD 4152214810 ext 6565 yue.leng@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03256539
Other Study ID Numbers  ICMJE 1K99AG056598-01( U.S. NIH Grant/Contract )
1K99AG056598-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Yue Leng, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP