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The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.
The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poor sleep group treatment 1 | Experimental | 10mg Suvorexant tablet h.s. for two consecutive nights |
|
| Poor sleep group control | Placebo Comparator | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. |
|
| Good sleep group | Placebo Comparator | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. |
|
| Poor sleep group treatment 2 | Experimental | 20mg Suvorexant tablet h.s. for two consecutive nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml | Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group) | 36 hours of CSF collection |
| Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml | Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2) | 36 hours of CSF collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Lucey, MD | Washington University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63144 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Poor Sleep Group Control | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
| FG001 | Poor Sleep Group Treatment 1 | 10mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. |
| FG002 | Poor Sleep Group Treatment 2 | 20mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. |
| FG003 | Good Sleep Group | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There was a 6th participant in the Good sleep group that had a lumbar catheter placed. However, minimal CSF was collected at a majority of the timepoints. There was insufficient samples of CSF collected to measure amyloid-beta (minimum volume needed was 0.5 ml at each timepoint). The participant agreed to continue the study for collection of blood and to try and continue collecting CSF, but would not agree to replacing the lumbar catheter.
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| ID | Title | Description |
|---|---|---|
| BG000 | Poor Sleep Group Control | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml | Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group) | Posted | Mean | Standard Deviation | ng/ml | 36 hours of CSF collection |
|
Adverse event data was collected from when the participants were consented into the study until 48 hours after the lumbar catheter was removed (~3 months).
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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 | Poor Sleep Group Control | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brendan Lucey | Washington University in St Louis School of Medicine | 314-747-3805 | luceyb@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | Mar 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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|
| Placebo | Drug | Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
|
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Poor Sleep Group Treatment 1 |
10mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. |
| BG002 | Poor Sleep Group Treatment 2 | 20mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. |
| BG003 | Good Sleep Group | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. |
|
|
|
| Primary | Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml | Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2) | Posted | Mean | Standard Deviation | ng/ml | 36 hours of CSF collection |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 10 |
| 13 |
| EG001 | Poor Sleep Group Treatment 1 | 10mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG002 | Poor Sleep Group Treatment 2 | 20mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG003 | Good Sleep Group | Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. | 0 | 6 | 0 | 6 | 4 | 6 |
| Headache requiring blood patch | Nervous system disorders | Non-systematic Assessment | Headache requiring blood patch after removal of lumbar catheter |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Presyncope with lumbar catheter placement | Cardiac disorders | Non-systematic Assessment |
|
| Back/neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Rash, swelling, or bruising at lumbar catheter site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ringing in ears | Ear and labyrinth disorders | Non-systematic Assessment |
|
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|
| Amyloid-beta-42 concentration at hour 4 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 6 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 8 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 10 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 12 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 14 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 16 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 18 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 20 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 22 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 24 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 26 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 28 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 30 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 32 (ng/ml) |
|
| Amyloid-beta-42 concentration at hour 34 (ng/ml) |
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| Amyloid-beta-42 concentration at hour 36 (ng/ml) |
|
| Mixed Models Analysis |
| 0.05 |
After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group. |
| Mean Difference (Final Values) |
| 0.033 |
| Standard Error of the Mean |
| 0.033 |
| 2-Sided |
| 95 |
| -0.051 |
| 0.117 |
| Superiority |