Primary Hyperparathyroidism Clinical Trial
Official title:
Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
Verified date | March 2024 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | June 29, 2024 |
Est. primary completion date | March 12, 2024 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03931109 -
Circulating miRNA in Primary Hyperparathyroidism
|
||
Completed |
NCT04305561 -
Preoperative Localization Strategies in Primary Hyperparathyroidism
|
N/A | |
Recruiting |
NCT03052075 -
Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
|
||
Completed |
NCT03774771 -
Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism
|
Phase 2 | |
Recruiting |
NCT02854345 -
Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera
|
N/A | |
Completed |
NCT01222026 -
Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
|
Phase 4 | |
Recruiting |
NCT00973336 -
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?
|
Phase 2 | |
Completed |
NCT01530919 -
Minimally Invasive Radioguided Parathyroidectomy
|
N/A | |
Recruiting |
NCT03605472 -
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
|
N/A | |
Completed |
NCT01306656 -
Vitamin D Repletion in Primary Hyperparathyroidism
|
Phase 4 | |
Terminated |
NCT00961701 -
Lipids Profile in Primary Hyperparathyroidism
|
N/A | |
Completed |
NCT00432939 -
Primary Hyperparathyroidism: Non-classical Manifestations
|
N/A | |
Completed |
NCT00522028 -
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
|
N/A | |
Completed |
NCT03713671 -
Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
|
N/A | |
Recruiting |
NCT04969926 -
Natural History Study of Parathyroid Disorders
|
||
Recruiting |
NCT03039439 -
Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
|
||
Not yet recruiting |
NCT03732157 -
Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
|
||
Completed |
NCT01996072 -
EC17 for Intraoperative Imaging for Parathyroidectomy
|
Phase 1 | |
Completed |
NCT01460030 -
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
|
Phase 3 | |
Enrolling by invitation |
NCT04085419 -
Osteoporosis in Primary Hyperparathyroidism
|
Phase 4 |