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Completed

NCT Number: NCT04683640

Latent Aging Mechanisms in Pain and Sleep

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

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

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

  • 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;
  • 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

Treatment and study plan

GABA

Dietary Supplement

Daily oral GABA for 4 weeks

Other names: Gamma aminobutyric acid

Placebo

Drug

Daily oral Placebo for 4 weeks

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline

    Time frame: 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.

  2. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention

    Time frame: Immediately post-intervention (4 weeks)

    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.

  3. Pain Detect at Baseline

    Time frame: 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.

  4. Pain Detect at Post-Intervention

    Time frame: Immediately post-intervention (4 weeks)

    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.

  5. Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline

    Time frame: 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.

  6. Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention

    Time frame: Immediately post-intervention (4 weeks)

    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.

  7. Epworth Sleepiness Scale (ESS) at Baseline

    Time frame: 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.

  8. Epworth Sleepiness Scale (ESS) at Post-Intervention

    Time frame: Immediately post-intervention (4 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)
  • Thorne HealthTech, Inc

Registry information

Official study title

Sleep, Pain and Aging: Potential Underlying Mechanisms

Acronym: LAMPS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2020
Registry last updated
Jul 18, 2025

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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