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Completed

NCT Number: NCT06337825

Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism

Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Multinodular Goiter Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

Primary hyperparathyroidism (PHPT) may be more common than previously assumed.1 Historically, osteoporosis and nephrolithiasis were the only two indications for parathyroidectomy (PTX) based on symptomology.2 All other patients, even in the presence of non-specific symptoms related to PHPT, were not routinely recommended for surgery. Nowadays, however, there is increased understanding that a patient's quality of life (QOL) may be adversely affected by these non-specific symptoms.3 The American Association of Endocrine Surgeons (AAES) strongly recommends PTX in patients with these non-specific symptoms if they can be attributed to PHPT.4 Despite this, these neuropsychiatric, musculoskeletal, and gastrointestinal symptoms are overall difficult to quantify and the improvements in symptoms are mostly measured with QOL surveys.

Even QOL surveys are subjective, and therefore, this may be a major barrier in broadening the indications for parathyroidectomy in patients with PHPT. To this day, there is no proposed objective metrics to quantify these improvements after parathyroidectomy.

Furthermore, the effect of PHPT on cardiovascular risk has been studied, but so far the results are conflicting. The mechanisms for this increased cardiovascular risk are not fully understood.

Nonetheless, this population demonstrates higher rates of hypertension, dyslipidemia, obesity, diabetes, and atherosclerosis compared to the general population. On the other hand, depression and sleep disturbances are also known factors for these comorbidities. It is possible that the neuropsychiatric symptoms of PHPT may contribute to a sedentary lifestyle and thus increase the cardiovascular risk. The association between these two have not been studied.

Who can participate

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

Inclusion criteria

  • Study group: Consecutive patients older than 18 years old who will undergo PTX for PHPT. The indications and need for surgery will be independent from the research team.
  • Control group: Consecutive patients older than 18 years old who will undergo thyroidectomy for multinodular goiter (MNG). The indications and need for surgery will be independent from the research team.

Exclusion criteria

  • Patients with recurrent or persistent PHPT will not be included.
  • Patients who are included but have evidence of recurrent or persistent PHPT based on six-month laboratory workup will be excluded from the final analysis (<5% expected)4.
  • Established diagnosis of thyroid cancer or Graves' disease.
  • Musculoskeletal or neurologic disorders that affect the patient's activity level.
  • Cardiac arrhythmias that would interfere with the wearable electronic device measurement.
  • Sleep apnea and other sleep disturbances undergoing concurrent treatment.

Treatment and study plan

Activity Tracker (Fitbit)

Behavioral

Wearable, activity tracker

HBA1C

Diagnostic Test

Average blood glucose (sugar) levels reported as a percentage

The PROMPT Questionnaire

Behavioral

The PROMPT Questionnaire which is a 30-question previously validated assessment for non-specific symptoms in PHPT, will be administered to patients preoperatively and at 2-weeks and 6-months postoperatively

Primary outcomes

  1. Change in resting heart rate over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in resting heart rate before and after parathyroidectomy in patients with Primary hyperparathyroidism

  2. Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in number of awakenings during sleep before and after parathyroidectomy in patients with Primary hyperparathyroidism

  3. Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in % Deep Sleep over Total Sleep Minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism

  4. Change in steps over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in steps before and after parathyroidectomy in patients with Primary hyperparathyroidism

  5. Change in total active minutes over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in total active minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism

  6. Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker

    Time frame: 7 months

    To assess the change in % Active Calorie over Total Calories before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7. Change in glucose levels (HbA1C)

    Time frame: 7 months

    To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.

  8. Correlation of Quality of Life surveys with the PROMPT survey

    Time frame: 7 months

    To correlate the measurements of patient health parameters with quality of life surveys before and after parathyroidectomy. This survey is comprised of 30 questions each with a 1 - 5 rating scale where lower scores indicate less pain, fatigue, soreness and higher scores indicate more fatigue, pain, soreness etc.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Aug 6, 2024

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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