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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06337825
• Other study ID #: 22-727
• Status: Active, not recruiting
• Start date: July 19, 2022
• Est. completion date: June 29, 2024

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 29, 2024
• Est. primary completion date: March 12, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Multinodular Goiter
• Primary Hyperparathyroidism

Intervention

Behavioral:
• Activity Tracker (Fitbit)
Wearable, activity tracker

Diagnostic Test:
• HbA1C
Average blood glucose (sugar) levels reported as a percentage

Behavioral:
• The PROMPT Questionnaire
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

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 months
Primary	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	7 months
Primary	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	7 months
Primary	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	7 months
Primary	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	7 months
Primary	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	7 months
Primary	Change in glucose levels (HbA1C)	To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.	7 months
Primary	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.	7 months