Chronic PainPhase 2LAMPSNCT04683640

Latent Aging Mechanisms in Pain and Sleep

A Phase 2 study testing GABA in people with Chronic Pain, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 100 years
Conditions the study is for: Chronic Pain
What is being tested?: GABA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 2 Apr 2021to 30 May 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Older adults 45 years of age or older who experienced pain of at least moderate intensity (>5/10 pain intensity ratings) on more days than not during the past three months, and who also reported poor sleep quality (>5 PSQI scores) will be considered for participation.

Who cannot join

serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
history of alcohol/drug abuse;
Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77;
hospitalizations for mental health reasons in the past year;
chronic/current use of narcotic medications;

Show all 19Show fewer

serious systemic (uncontrolled diabetes self-reported HA1C>7), (uncontrolled hypertension > 155/90 mm Hg) and rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia, HIV);
arterial hypotension;
digestive tract diseases;
major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
excessive anxiety regarding protocol procedures;
Inability to consent for study participation;
Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others);
Neuropathic pain medications including anticonvulsants and antidepressants;
Allergies or sensitivity to GABA or its ingredients cellulose' gelatin (capsule)' magnesium silicate' vegetable stearate and silica or to the placebo or its ingredients: calcium laurate, hypromellose capsule, magnesium (citrate), microcrystalline cellulose;
currently taking barbiturate and benzodiazepine and baclofen;
MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia;
current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Sleep, Pain and Aging: Potential Underlying Mechanisms

Chronic pain is a serious public health problem in older adults depending on the pain condition, and the capacity to sleep properly changes with age. Given the potential mechanistic role of GABA (gamma-aminobutyric acid) in both conditions, based on our preliminary data, this proposal will determine the effect of oral GABA administration in sleep quality and pain in older adults with chronic pain and sleep disorders as well as to characterize the potential neurobiological mechanisms involved in both illnesses.

Conditions: Chronic Pain
Being tested: GABA, Placebo
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GABADietary supplement
Also called Gamma aminobutyric acid
Daily oral GABA for 4 weeks
PlaceboDrug
Daily oral Placebo for 4 weeks

Study groups in NCT04683640
Study group	Role	What they receive
Daily Oral GABA	Experimental	You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks Receives: Dietary Supplement: GABA
Daily Placebo	Placebo comparator	You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
Measured: PSQI was administered at baseline
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
Measured: PSQI was administered immediately after completing the 4-week intervention
Verbal Descriptor Scale (VDS) at Baseline
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
Measured: VDS was administered at baseline
Verbal Descriptor Scale (VDS) at Post-Intervention
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
Measured: VDS was administered immediately after completing the 4-week intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
Measured: WOMAC was administered at baseline.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
Measured: WOMAC was administered after completing the 4-week intervention

Secondary outcomes (8)

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline
The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.
Measured: Baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention
The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.
Measured: Immediately post-intervention (4 weeks)
Pain Detect at Baseline
The PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.
Measured: Baseline
Pain Detect at Post-Intervention
The PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.
Measured: Immediately post-intervention (4 weeks)
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline
The Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.
Measured: Baseline
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention
The Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.
Measured: Immediately post-intervention (4 weeks)
Epworth Sleepiness Scale (ESS) at Baseline
The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
Measured: Baseline
Epworth Sleepiness Scale (ESS) at Post-Intervention
The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
Measured: Immediately post-intervention (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202130 May 2024

First posted24 Dec 2020
Study start2 Apr 2021
Primary completion30 May 2024
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04683640
Sponsor's protocol ID: IRB202000105-N
Other IDs: P30AG059297
Acronym: LAMPS
Status last verified: Jun 2025
First submitted: 21 Dec 2020
Last updated: 18 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep, Pain and Aging: Potential Underlying Mechanisms
ClinicalTrials.gov ID: NCT04683640
Acronym / sponsor ID: LAMPS / IRB202000105-N
Conditions: Chronic Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Thorne HealthTech, Inc
Study start: 2 Apr 2021 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 24 Dec 2020 (actual)
Results: Posted 18 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Daily Oral GABA	Experimental	Dietary Supplement: GABAYou will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
Daily Placebo	Placebo comparator	Drug: PlaceboYou will take, by mouth, 2 pills of Placebo daily at home for 4 weeks

Who may qualify

Ages: 45 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Older adults 45 years of age or older who experienced pain of at least moderate intensity (>5/10 pain intensity ratings) on more days than not during the past three months, and who also reported poor sleep quality (>5 PSQI scores) will be considered for participation.

Key exclusion criteria (19 listed)

serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
history of alcohol/drug abuse;
Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77;
hospitalizations for mental health reasons in the past year;

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
GABAAlso: Gamma aminobutyric acidDaily oral GABA for 4 weeks	Dietary supplement	Daily Oral GABA
PlaceboDaily oral Placebo for 4 weeks	Drug	Daily Placebo

Primary outcome

The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline
Time frame: PSQI was administered at baseline
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention
Time frame: PSQI was administered immediately after completing the 4-week intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
Verbal Descriptor Scale (VDS) at Baseline
Time frame: VDS was administered at baseline
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
Verbal Descriptor Scale (VDS) at Post-Intervention
Time frame: VDS was administered immediately after completing the 4-week intervention
The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline
Time frame: WOMAC was administered at baseline.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention
Time frame: WOMAC was administered after completing the 4-week intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.

8 secondary outcomes

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline
Time frame: Baseline
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention
Time frame: Immediately post-intervention (4 weeks)
Pain Detect at Baseline
Time frame: Baseline
Pain Detect at Post-Intervention
Time frame: Immediately post-intervention (4 weeks)
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline
Time frame: Baseline
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention
Time frame: Immediately post-intervention (4 weeks)
Epworth Sleepiness Scale (ESS) at Baseline
Time frame: Baseline
Epworth Sleepiness Scale (ESS) at Post-Intervention
Time frame: Immediately post-intervention (4 weeks)

Results and safety

Results posted to the registry on 18 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLACEBO	15	13
GABA	18	17

Primary outcome: The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline

Time frame: PSQI was administered at baseline. Mean (Standard Deviation). Unit: Score on scale

Measure	PLACEBO n = 15	GABA n = 18
Value	11.20 (4.18)	9.78 (3.02)

Population analysed: Baseline characteristics for the Pittsburgh Sleep Quality Index (PSQI) are reported for participants who completed the baseline assessment and had complete PSQI data.

Primary outcome: The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention

Time frame: PSQI was administered immediately after completing the 4-week intervention. Mean (Standard Deviation). Unit: Score on scale

Measure	PLACEBO n = 13	GABA n = 18
Value	8.08 (3.59)	7.89 (3.23)

Population analysed: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the PSQI at the post-intervention time point and were therefore excluded from the post-intervention analysis. All other participants included had complete data.

Primary outcome: Verbal Descriptor Scale (VDS) at Baseline

Time frame: VDS was administered at baseline. Median (Inter-Quartile Range). Unit: Scores on a scale

Measure	PLACEBO n = 15	GABA n = 18
Value	2.00 (1 to 2)	1.50 (1 to 2)

Population analysed: The analysis population for the Verbal Descriptor Scale (VDS) at baseline includes all participants who were assigned to Group A (n=15) and Group B (n=18), as all completed the baseline assessment.

Primary outcome: Verbal Descriptor Scale (VDS) at Post-Intervention

Time frame: VDS was administered immediately after completing the 4-week intervention. Median (Inter-Quartile Range). Unit: Score on scale

Measure	PLACEBO n = 13	GABA n = 18
Value	1 (0.50 to 2)	1 (1 to 2)

Population analysed: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the VDS at the post-intervention time point and were therefore excluded from the post-intervention analysis. All other participants included had complete data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of the intervention through 3 months post-intervention. Adverse events were actively monitored weekly during the 4-week treatment phase and followed up for an additional 3 months after study completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO	0 of 15 (0%)	12 of 15 (80%)	0 of 15
GABA	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18

Limitations and caveats (from the sponsor): This study was a single-site, proof-of-concept trial with a relatively small sample size, which may limit generalizability. The study remained blinded at the time of reporting; group assignments were not unmasked for outcome comparisons. Some outcome measures had missing post-intervention data, particularly in Group A, potentially impacting statistical power. The adverse event reporting table may reflect minor inconsistencies in total counts due to repeat occurrences per participant.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Yenisel Cruz-Almeida, MSPH, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GABA in people with Chronic Pain, run by University of Florida at 1 site in United States.

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 1 inclusion and 19 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 18 Jul 2025. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline (time frame: PSQI was administered at baseline). The study lists 6 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 NCT04683640.

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 18 Jul 2025.