Insomnia Due to Anxiety and FearSleep-AidNCT05280561
Stress-induced Sleep Deficits and a Complementary Therapy
A study testing DHM in people with Insomnia Due to Anxiety and Fear, run by University of Southern California at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Due to Anxiety and Fear
- What is being tested?
- DHM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2021to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential 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.
- Conditions
- Insomnia Due to Anxiety and Fear
- Being tested
- DHM, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHMDietary supplement
DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic
PlaceboDietary supplement
Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
| Study group | Role | What they receive |
|---|---|---|
| DHM group | Experimental | 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. Receives: Dietary Supplement: DHM |
| Control group | Placebo comparator | The placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of DHM on sleep duration
Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo.
Measured: 20 days
Effect of DHM on stress levels
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.
Measured: 20 days
Effect of DHM on cellphone time
Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo.
Measured: 20 days
Effect of DHM on feelings after waking up
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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start25 Jul 2021
- Primary completion31 Oct 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insomnia Due to Anxiety and FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Jing Liang, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280561
- Sponsor's protocol ID
- UP-21-00653
- Acronym
- Sleep-Aid
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shen Y, Lindemeyer AK, Gonzalez C, Shao XM, Spigelman I, Olsen RW, Liang J. Dihydromyricetin as a novel anti-alcohol intoxication medication. J Neurosci. 2012 Jan 4;32(1):390-401. doi: 10.1523/JNEUROSCI.4639-11.2012.
PubMed 22219299Liang J, Lopez-Valdes HE, Martinez-Coria H, Lindemeyer AK, Shen Y, Shao XM, Olsen RW. Dihydromyricetin ameliorates behavioral deficits and reverses neuropathology of transgenic mouse models of Alzheimer's disease. Neurochem Res. 2014 Jun;39(6):1171-81. doi: 10.1007/s11064-014-1304-4. Epub 2014 Apr 13.
PubMed 24728903Silva J, Shao AS, Shen Y, Davies DL, Olsen RW, Holschneider DP, Shao XM, Liang J. Modulation of Hippocampal GABAergic Neurotransmission and Gephyrin Levels by Dihydromyricetin Improves Anxiety. Front Pharmacol. 2020 Jul 9;11:1008. doi: 10.3389/fphar.2020.01008. eCollection 2020.
PubMed 32742262
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy
- ClinicalTrials.gov ID
- NCT05280561
- Acronym / sponsor ID
- Sleep-Aid / UP-21-00653
- Conditions
- Insomnia Due to Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DHM group | Experimental | Dietary Supplement: DHMThis 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. |
| Control group | Placebo comparator | Dietary Supplement: PlaceboThe placebo contained excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHMDHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic | Dietary supplement | DHM group |
| PlaceboExcipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g | Dietary supplement | Control group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Results publication: PubMed 22219299Shen Y, Lindemeyer AK, Gonzalez C, Shao XM, Spigelman I, Olsen RW, Liang J. Dihydromyricetin as a novel anti-alcohol intoxication medication. J Neurosci. 2012 Jan 4;32(1):390-401. doi: 10.1523/JNEUROSCI.4639-11.2012.
- Results publication: PubMed 24728903Liang J, Lopez-Valdes HE, Martinez-Coria H, Lindemeyer AK, Shen Y, Shao XM, Olsen RW. Dihydromyricetin ameliorates behavioral deficits and reverses neuropathology of transgenic mouse models of Alzheimer's disease. Neurochem Res. 2014 Jun;39(6):1171-81. doi: 10.1007/s11064-014-1304-4. Epub 2014 Apr 13.
- Results publication: PubMed 32742262Silva J, Shao AS, Shen Y, Davies DL, Olsen RW, Holschneider DP, Shao XM, Liang J. Modulation of Hippocampal GABAergic Neurotransmission and Gephyrin Levels by Dihydromyricetin Improves Anxiety. Front Pharmacol. 2020 Jul 9;11:1008. doi: 10.3389/fphar.2020.01008. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHM in people with Insomnia Due to Anxiety and Fear, run by University of Southern California at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of DHM on sleep duration (time frame: 20 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280561, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.