Insomnia Due to Anxiety and Fear
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDHM
DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic
DIETARY_SUPPLEMENTPlacebo
Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
Sponsors
University of California, Los Angeles
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of DHM on sleep duration | 20 days | Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo. |
| Effect of DHM on stress levels | 20 days | 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. |
| Effect of DHM on cellphone time | 20 days | Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo. |
| Effect of DHM on feelings after waking up | 20 days | 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. |
Countries
China
Outcome results
None listed