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The purpose of this research is to evaluate the effect of a sustained-release, lower-dosage (150mg) Ashwagandha supplement to reduce disturbed sleep. 54 participants, after randomization, will take either an Ashwagandha supplement or a placebo daily for 28 days (week 4) and wear an Oura ring. The Oura ring will measure waking after sleep onset (WASO). Questionnaires to evaluate quality of life and sleep will be administered at baseline and week 4.
Each participant will be in the study for about 5 weeks (1 preparation week and 4 weeks for the trial). Questionnaires consist of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained-Release Ashwagandha Supplement | Experimental | Sustained-release, lower-dosage (150mg) Ashwagandha supplement; 1 capsule 1 time per day. |
|
| Placebo | Placebo Comparator | Placebo Supplement: Consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ashwagandha | Dietary Supplement | Sustained-Release, lower-dosage (150mg) Ashwagandha Supplement, 1 capsule 1 time per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance: Change from Baseline in the Mean Waking After Sleep Onset (WASO) to Week 4 | WASO is measured nightly in hours and minutes via an Oura Ring. The Oura Ring must be worn at least 4 nights per week on average from Baseline (7 days) + 28 days. Primary analysis: Change in WASO will be measured as the average of the final 4 days of Week 4 minus the average WASO of the Baseline Week. Secondary analysis: Change in WASO will be measured as the average of Week 4 minus the average WASO of the Baseline Week. | From Baseline to Week 4 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Mean Patient-Reported Outcomes Measurement Information System (PROMIS-29) Sleep Disturbance Subdomain to Week 4 | Subjective sleep disturbance measured via the PROMIS-29 Profile v2.0 Sleep Disturbance Subdomain. The raw sleep disturbance summed scores range from 4 to 20, with T-scores ranging 32.0 to 73.3, respectively. For Sleep Disturbance, higher scores indicate worse health than average. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. The sleep quality question is measured as 1 "Very Good" to 5 "Very Poor." The sleep refreshing question is measured as 1 "Very Much" to 5 "Not at all." The two remaining questions problem with sleep and difficulty with sleep are both measured as 1 "Not at all" to 5 "Very Much." |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Mean PROMIS-29 Fatigue Subdomain to Week 4 | Subjective Fatigue measured via the PROMIS-29 Profile v2.0 Fatigue Subdomain. The raw fatigue summed scores range from 4 to 20, with T-scores ranging 33.7 to 75.8, respectively. For Fatigue, higher scores indicate worse health than average. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. All four fatigue questions are measured as 1 "Not at all" to 5 "Very much." |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Goldenberg, ND | National University of Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Natural Medicine | Portland | Oregon | 97201 | United States |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C030693 | Ashwagandha |
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| Placebo | Other | This placebo does not contain any of the interventional dietary supplement. The placebo consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day. |
|
| From Baseline to End of Week 4 (28 days) |
| Change from Baseline in Mean PROMIS-29 Sleep Quality Question to Week 4 | Sleep quality measured via the PROMIS-29 Sleep Quality question. Scores range from 1 "Very Good" to 5 "Very Poor" | From Baseline to End of Week 4 (28 days) |
| Baseline to End of Week 4 (28 days) |
| Change from Baseline in the Mean PROMIS-29 Anxiety Subdomain to Week 4 | Subjective anxiety measured via the PROMIS-29 Profile v2.0 Anxiety Subdomain. The anxiety summed scores range from 4 to 20, with T-scores ranging from 40.3 to 81.6, respectively. For Anxiety, higher scores indicated worse health than average. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. All four anxiety questions are measured as 1 "Never" to 5 "Always." | From baseline to End of Week 4 (28 days) |
| Change from Baseline in the Mean PROMIS-29 Depression Subdomain to Week 4 | Subjective depression measured via the PROMIS-29 Profile v2.0 Depression Subdomain. The raw depression summed scores range from 4 to 20, with T-scores ranging from 41.0 to 79.4, respectively. For Depression, higher scores indicate worse health than average. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. All four depression questions are measured as 1 "Never" to 5 "Always." | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Sleep Onset Latency (SOL) to Week 4 | SOL is measured objectively via an Oura Ring in seconds. SOL is measured from the local time when the sleep period started, based on the connected mobile device clock, to the beginning of the first 5 minutes of persistent sleep. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Sleep Efficiency (SE) to Week 4 | Sleep Efficiency (SE) is measured as a range from 1 to 100. It is the percentage of the sleep period spent asleep (sleep total divided by sleep duration X 100%). | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Total Sleep Duration to Week 4 | Total sleep duration is measured objectively via an Oura ring. It is the total amount of sleep measured in seconds (total sleep duration = rem sleep +light sleep + deep sleep). | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Sleep Duration in Rapid Eye Movement (REM) to Week 4 | Sleep duration in REM is measured in seconds and objectively via an Oura ring. It is the total amount of REM sleep that is registered during the sleep period. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Light Sleep Duration to Week 4 | Light Sleep Duration is measured in seconds and objectively via an Oura ring. It is the total amount of light sleep measured during the sleep period. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Deep Sleep Duration to Week 4 | Deep sleep duration is measured in seconds and objectively via an Oura ring. It is the total amount of deep sleep registered during the sleep period. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Time in Bed to Week 4 | Time in bed is measured in seconds and objectively via an Oura ring. It is the total duration of the sleep period (Time in Bed = total sleep duration + awake time). | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Heart Rate to Week 4 | Heart rate is the average heart rate registered during the sleep period via an Oura ring. It is measured in beats per minute. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Heart Rate Variability to Week 4 | Heart rate variability (HRV) is the average HRV calculated with RMSSD method via an Oura ring. It is measured in milliseconds. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Respiratory Rate | Respiratory rate is measured objectively by an Oura ring. It is the average respiratory rate in breaths per minute. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Body Temperature to Week 4 | Body Temperature is measured objectively by an Oura ring. Body temperature, measured in Celsius, is the skin temperature deviation from the long-term temperature average. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of Daily Sleep Score to Week 4. | The Daily Sleep Score is composed of multiple sleep aspects collected by the Oura Ring, including deep sleep, rem sleep, efficiency, latency, restfulness, timing, and total sleep. Its score range is 0-100 (or Null if N/A). The Daily Sleep Score represents the overall sleep quality during the sleep period. It is calculated as a weighted average of sleep score contributors that each represent on aspect of sleep quality. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean Daily Resilience Score to Week 4 | The Daily Resilience Score is composed of various data collected by the Oura ring, including sleep recovery, daytime recovery, and stress. The scores range from 1-100 (or Null if N/A). | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of High Stress to Week 4 | High stress is the amount of stressed time in seconds that is calculated from stress samples detected by an Oura ring. | From Baseline to Week 4 (28 days) |
| Change from Baseline in the Mean of High Recovery to Week 4 | High recovery is defined as the amount of recovery time in seconds calculated from stress samples identified by an Oura ring. | From Baseline to Week 4 (28 days) |