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NCT04100057 · ClinicalTrials.gov registry record · NA
Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia
A NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04100057: Recruiting NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Stanford University.
NCT04100057 is a NA study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by Stanford University. The registered enrollment target is 150 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04100057, a NA study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week thro
Primary Outcome
Fronto-limbic function will be assessed through functional magnetic resonance imaging.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
- BEHAVIORAL Desensitization Therapy for insomnia (DT-I)
Study Locations (1)
California
- Andrea Goldstein-Piekarski, PhD - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What NCT04100057 shows while recruiting
NCT04100057 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT04100057 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04100057 about?
NCT04100057 is a clinical study titled "Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia". Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion ...
What is the current status of trial NCT04100057?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-08-31. Estimated completion is 2026-11-30.
What conditions does trial NCT04100057 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Sleep Disturbance, Neuropsychiatric Symptoms.
What interventions are being tested in trial NCT04100057?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Desensitization Therapy for insomnia (DT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04100057?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04100057 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04100057's enrollment target sits among peer trials
150 129th of 306 higher than 176 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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