Stress-induced Sleep Deficits and a Complementary Therapy

Insomnia Due to Anxiety and Fear Clinical Trial

— Sleep-Aid  

Official title:

Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280561
• Other study ID #: UP-21-00653
• Status: Completed
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: November 3, 2022

Study information

• Verified date: January 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: November 3, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy subjects were recruited in Chengdu and Beijing (city) in China,
• Able and willing to sign informed consent,
• Between 18 -60 years old at time of consent,
• No alcohol, drug, and smoking,
• Not using sleep medication(s) or other psychiatric medications.

Exclusion Criteria:

• Pregnant or Breastfeeding women,
• Currently taking any medications for sleep,
• Reported naps > 3 times per week
• History of sleep apnea,
• Current alcohol, drug, and smoking

Related Conditions & MeSH terms

• Insomnia Due to Anxiety and Fear
• Sleep Deprivation

Intervention

Dietary Supplement:
• DHM
DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic
• Placebo
Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g

Locations

Country	Name	City	State
China	Furise Group Co	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California, Los Angeles

Country where clinical trial is conducted

China, 

References & Publications (3)

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. do — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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