Stress-induced Sleep Deficits and a Complementary Therapy (Sleep-Aid)

University of Southern California

Status: Completed

Conditions: Insomnia Due to Anxiety and Fear

Treatments: Dietary Supplement: DHM; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05280561

UP-21-00653

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups, including a placebo group

DHM group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DHM

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo