Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.
The purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health. This is a double-blind, randomized placebo-controlled crossover trial. Study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period [Block 1], 4-week washout, and 4-week treatment period [Block 2]). During each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suvorexant | Experimental | 20mg taken at bedtime for 4 weeks |
|
| placebo | Placebo Comparator | placebo taken at bedtime for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | 20mg taken at bedtime for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia. | baseline and end of each four-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Glucose Concentrations at 4 Weeks | Fasting glucose concentrations are determined from a blood sample collected at least 8 hours since last food intake. | baseline and end of each four-week intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shadab Rahman, PhD MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant, Then Placebo | Participants first received suvorexant tablet (20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. |
| FG001 | Placebo, Then Suvorexant | Participants first received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received suvorexant tablet (20mg) daily at bedtime for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 weeks) |
|
| ||||||||||||||||||||||||
| Washout Period (4 weeks) |
| |||||||||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant, Then Placebo | Participants first received suvorexant tablet (20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. |
| BG001 | Placebo, Then Suvorexant |
| 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 | Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia. | Posted | Mean | Standard Deviation | units on a scale | baseline and end of each four-week intervention |
|
Four weeks for each intervention
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suvorexant | Participants who received suvorexant tablet (20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mood symptoms | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shadab Rahman, PhD MPH | Brigham and Women's Hospital | 617-732-4015 | sarahman@bwh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2025 | Mar 31, 2026 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 30, 2025 | Mar 31, 2026 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2025 | Mar 31, 2026 | ICF_005.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551624 | suvorexant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | placebo taken at bedtime for 4 weeks |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
Participants first received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks. After a washout period of 4 weeks, they then received suvorexant tablet (20mg) daily at bedtime for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in Fasting Glucose Concentrations at 4 Weeks | Fasting glucose concentrations are determined from a blood sample collected at least 8 hours since last food intake. | Posted | Mean | Standard Deviation | mg/dL | baseline and end of each four-week intervention |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 3 |
| 27 |
| EG001 | Placebo | Participants who received placebo tablet (matching suvorexant 20mg) daily at bedtime for 4 weeks in either the first or second treatment block during the study. | 0 | 29 | 0 | 29 | 5 | 29 |
| headache | Nervous system disorders | Non-systematic Assessment |
|
| arthritic discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| skin irritation from continuous glucose monitor | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| malaise | General disorders | Non-systematic Assessment |
|
| somnolence | Nervous system disorders | Non-systematic Assessment |
|
| uveitis | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |