An observational study in Primary Hyperparathyroidism and Multinodular Goiter, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by The Cleveland Clinic · Observational
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.
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's enrollment of 45 is below the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Patients referred by other physicians for surgical treatment of PHPT and MNG will be identified in the outpatient schedule of our six endocrine surgeons at the Department of Endocrine Surgery, Endocrine and Metabolism Institute. The research team will be introduced to the patients via My Chart where we will request permission for a phone call to discuss the research study. Once they agree to participate, the recruitment will be done at the outpatient clinic in the Endocrine and Metabolism Institute at Main Campus on the day of their appointment. The need for surgery will be made by the treating surgeon with no involvement of the research team. The recruitment will be done by a member of the research team at the endocrine surgery center (F-20).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients undergoing parathyroidectomy for primary hyperparathyroidism
Behavioral: Activity Tracker (Fitbit) · Diagnostic Test: HbA1C · Behavioral: The PROMPT Questionnaire
patients undergoing thyroidectomy for multinodular goiter
Behavioral: Activity Tracker (Fitbit) · Diagnostic Test: HbA1C · Behavioral: The PROMPT Questionnaire
Wearable, activity tracker
Average blood glucose (sugar) levels reported as a percentage
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
Change in resting heart rate over time among study participants as monitored by fitness tracker
To assess the change in resting heart rate before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker
To assess the change in number of awakenings during sleep before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker
To assess the change in % Deep Sleep over Total Sleep Minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in steps over time among study participants as monitored by fitness tracker
To assess the change in steps before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in total active minutes over time among study participants as monitored by fitness tracker
To assess the change in total active minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker
To assess the change in % Active Calorie over Total Calories before and after parathyroidectomy in patients with Primary hyperparathyroidism
Time frame: 7 months
Change in glucose levels (HbA1C)
To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.
Time frame: 7 months
Correlation of Quality of Life surveys with the PROMPT survey
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.
Time frame: 7 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Mar 2024, 19 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Primary →