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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99AG056598-01 | U.S. NIH Grant/Contract | View source | |
| R00AG056598 | U.S. NIH Grant/Contract | View source |
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Unexpected closure of study components -- the digital intervention (CBT-I) was no longer accessible, and alternatives were not feasible.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Intervention | Experimental | Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT) |
|
| Placebo intervention | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep intervention | Behavioral | Behavioral sleep intervention program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled to the Study | Up to 24 weeks following study initiation | |
| Number of Participants That Complete the Study | Through study completion, up to 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep as Assessed by Actigraphy | Week-long measurement using wrist actigraphy | Through study completion, up to 34 weeks |
| Cognitive Function Assessed by Standard Neurocognitive Battery | Through study completion, up to 34 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yue Leng, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Intervention | An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment |
| FG001 | Placebo Intervention | Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Intervention | An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment |
| BG001 | Placebo Intervention | Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled to the Study | Posted | Count of Participants | Participants | Up to 24 weeks following study initiation |
|
|
Two years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep Intervention | An FDA-authorized prescription digital cognitive behavioral therapy for insomnia (CBT-I) therapeutic treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yue Leng | University of California, San Francisco | 415 502 2949 | yue.leng@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2023 | Apr 9, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2023 | Apr 9, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2023 | Apr 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo intervention |
| Behavioral |
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) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) ranges from 0-21, with higher scores indicating worse sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Insomnia Severity Index (ISI) | The Insomnia Severity Index (ISI) ranges from 0-28, with higher scores indicating worse insomnia symptoms. Scoring is as follows: 0 - 7 No clinically significant insomnia; 8 - 14 Subthreshold insomnia; 15 - 21 Clinical insomnia (moderate severity); 22 - 28 Clinical insomnia (severe). | Mean | Standard Deviation | units on a scale |
|
| Quick Dementia Rating System (QDRS) Category | Count of Participants | Participants |
|
| STOP-BANG sleep apnea scale | The STOP-BANG sleep apnea scale assesses risk of sleep apnea and consists of eight yes or no questions. Scoring is as follows: Low Risk: Yes to 0 - 2 questions; Intermediate Risk: Yes to 3 - 4 questions; High Risk: Yes to 5 - 8 questions. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants That Complete the Study | Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Through study completion, up to 34 weeks |
|
|
| Secondary | Sleep as Assessed by Actigraphy | Week-long measurement using wrist actigraphy | Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Through study completion, up to 34 weeks |
|
|
| Secondary | Cognitive Function Assessed by Standard Neurocognitive Battery | Data were not collected due to study termination prior to participants' assessment at the pre-specified time points. | Posted | Through study completion, up to 34 weeks |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo Intervention | Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implements in the same frequency and duration). | 0 | 7 | 0 | 7 | 0 | 7 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |