Clinical trial NCT05280561: Stress-induced Sleep Deficits and a Complementary Therapy
Official title: Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Due to Anxiety and Fear
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2022-03-15
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 288 subjects were recruited for the study. The sample size was based on a prior power analyses using G-Power 3, for a Mixed Model Repeated Measures Analysis of Variance (MMRMA) design, assuming a statistical power of 0.8, moderate effects of the DHM effects on sleep outcomes, and hypothesis tests conducted at a probability value of .05.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of DHM on sleep duration
timeFrame: 20 days
measure: Effect of DHM on stress levels
timeFrame: 20 days
measure: Effect of DHM on cellphone time
timeFrame: 20 days
measure: Effect of DHM on feelings after waking up
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Furise Group Co
state: Sichuan
Study officials:
References:
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.
citation: 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.
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.2020.01008. eCollection 2020.