Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337825
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-03-12
Brief Title:
Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Primary hyperparathyroidism PHPT may be more common than previously assumed1 Historically osteoporosis and nephrolithiasis were the only two indications for parathyroidectomy PTX based on symptomology2 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 patients quality of life QOL may be adversely affected by these non-specific symptoms3 The American Association of Endocrine Surgeons AAES strongly recommends PTX in patients with these non-specific symptoms if they can be attributed to PHPT4 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None