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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
54
Sustained-Release, lower-dosage (150mg) Ashwagandha Supplement, 1 capsule 1 time per day.
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.
National University of Natural Medicine
Portland, Oregon, United States
RECRUITINGSleep 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.
Time frame: From Baseline to Week 4 (28 days)
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."
Time frame: 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"
Time frame: From Baseline to End of Week 4 (28 days)
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