Latent Aging Mechanisms in Pain and Sleep (LAMPS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Dietary supplement: GABA; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
2. history of alcohol/drug abuse;
3. Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
4. significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77;
5. hospitalizations for mental health reasons in the past year;
6. chronic/current use of narcotic medications;
7. 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);
8. arterial hypotension;
9. digestive tract diseases;
10. major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
11. excessive anxiety regarding protocol procedures;
12. Inability to consent for study participation;
13. Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others);
14. Neuropathic pain medications including anticonvulsants and antidepressants;
15. 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;
16. currently taking barbiturate and benzodiazepine and baclofen;
17. MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia;
18. current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
19. pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily Oral GABA; You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks	Dietary supplement: GABA; Daily oral GABA for 4 weeks; Other Names: Gamma aminobutyric acid
Placebo Comparator: Daily Placebo; You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks	Drug: Placebo; Daily oral Placebo for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	WOMAC was administered after completing the 4-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Immediately post-intervention (4 weeks)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA); Thorne HealthTech, Inc
• Investigators: Principal Investigator: Yenisel Cruz-Almeida, MSPH, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; GABA Agents; gamma-Aminobutyric Acid
• Other Study ID Numbers: IRB202000105-N; P30AG059297 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No