Stress-induced Sleep Deficits and a Complementary Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-25

Study Completion Date

2022-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia Due to Anxiety and Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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DHM group

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.

Group Type EXPERIMENTAL

DHM

Intervention Type DIETARY_SUPPLEMENT

DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic

Control group

The placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g

Interventions

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DHM

DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic

Intervention Type DIETARY_SUPPLEMENT

Placebo

Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes