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Completed

NCT Number: NCT05280561

Stress-induced Sleep Deficits and a Complementary Therapy

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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Key information

Conditions

Insomnia Due to Anxiety and Fear

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Furise Group Co

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHM

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Effect of DHM on sleep duration

    Time frame: 20 days

    Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo.

  2. Effect of DHM on stress levels

    Time frame: 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.

  3. Effect of DHM on cellphone time

    Time frame: 20 days

    Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo.

  4. Effect of DHM on feelings after waking up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy

Acronym: Sleep-Aid

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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