Sleep-Aid
Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy
Sponsor study identifier
interventional
288
1 country
1
Study Start
July 25, 2021
Actual (reported)Primary Completion
October 31, 2022
Actual (reported)Study Completion
November 3, 2022
Actual (reported)The COVID-19 pandemic and social isolation order induced stress/anxiety as well as cellphone dependence. As a result, sleep disruption and mental distress became major health concerns. Gamma-aminobutyric acid type-A receptor (GABAAR) is one of the key players in modulating sleep. Dihydromyricetin (DHM), an herbal compound, plays a role in GABAAR modulation and mitigating anxiety. The investigators' partner in China obtained 288 participants who completed the online survey to gain insight into how stress/anxiety and time spent on cellphones affected sleep and mood. The participants were then enrolled in a randomized placebo-controlled double-blind study to assess the effects of DHM on sleep and improvement on stress/anxiety and cellphone using time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 3, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2021
Actual (reported)February 11, 2022
Actual (reported)March 15, 2022
Actual (reported)October 31, 2022
Actual (reported)November 3, 2022
Actual (reported)Effect of DHM on sleep duration
Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo.
20 days
Effect of DHM on stress levels
Changes in stress levels reported as the difference between self-reported stress levels before and after DHM or placebo. Stress levels were scaled from 0 to 10, with 10 being the highest stress level.
20 days
Effect of DHM on cellphone time
Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo.
20 days
Effect of DHM on feelings after waking up
Changes in negative feelings after waking up, reported as the difference between the self-reported negative feelings before and after DHM or placebo. In the survey, "feelings after waking up" included negative feelings such as tense, lack of motivation, and irritable/angry. To quantify these feelings, a 'Yes' counted as -1 point, a 'No' counted as 0 points, and a 'Not sure' counted as -0.5 points. The sum of these scores were calculated as the total negative feeling after waking up. Lower score (more negative) indicated worse feelings.
20 days
This arm is to evaluate DHM effects on the intervention of stress-induced insomnia during the pandemic. DHM granular preparation contains DHM 200 mg plus same excipients as placebo. The 244 participants were taken DHM granular preparation, which was dissolved in \~100 ml water for oral administration, once daily for 20 days.
The placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic
Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
Furise Group Co
Chengdu, Sichuan, China
Shen Y, Lindemeyer AK, Gonzalez C, Shao XM, Spigelman I, Olsen RW, Liang J. Dihydromyricetin as a novel anti-alcohol intoxication medication. J Neurosci. 2012 Jan 4;32(1):390-401. doi: 10.1523/JNEUROSCI.4639-11.2012.
Liang J, Lopez-Valdes HE, Martinez-Coria H, Lindemeyer AK, Shen Y, Shao XM, Olsen RW. Dihydromyricetin ameliorates behavioral deficits and reverses neuropathology of transgenic mouse models of Alzheimer's disease. Neurochem Res. 2014 Jun;39(6):1171-81. doi: 10.1007/s11064-014-1304-4. Epub 2014 Apr 13.
288 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2022
First Posted
March 15, 2022
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Silva J, Shao AS, Shen Y, Davies DL, Olsen RW, Holschneider DP, Shao XM, Liang J. Modulation of Hippocampal GABAergic Neurotransmission and Gephyrin Levels by Dihydromyricetin Improves Anxiety. Front Pharmacol. 2020 Jul 9;11:1008. doi: 10.3389/fphar.2020.01008. eCollection 2020.
Study Start
July 25, 2021
Actual (reported)Primary Completion
October 31, 2022
Actual (reported)Study Completion
November 3, 2022
Actual (reported)Last Updated
January 5, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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