Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyp… (NCT06337825) | Clinical Trial Compass
CompletedNot Applicable
Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism
United States45 participantsStarted 2022-07-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in resting heart rate over time among study participants as monitored by fitness tracker
Timeframe: 7 months
2
Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker
Timeframe: 7 months
3
Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker
Timeframe: 7 months
4
Change in steps over time among study participants as monitored by fitness tracker
Timeframe: 7 months
5
Change in total active minutes over time among study participants as monitored by fitness tracker
Timeframe: 7 months
6
Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker