Stress-induced Sleep Deficits and a Complementary Therapy

Not Applicable

Completed

• Conditions: Insomnia Due to Anxiety and Fear
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: DHM

• Registration Number: NCT05280561
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-25
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	The placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
DHM group	DHM	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Furise Group Co; 🇨🇳 Chengdu, Sichuan, China