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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT00501215 |
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Date of registration:
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12/07/2007 |
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Primary sponsor: |
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Public title:
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Effect of Parathyroidectomy on Sleep
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Scientific title:
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Pilot Study on the Effect of Parathyroidectomy on Sleep |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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12 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00501215 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nancy D. Perrier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or
high-normal serum calcium level greater than or equal to 10.0 mg/dL).
2. Have at least one of the following symptoms affecting sleep: a) not feeling refreshed
on awakening b) difficulty falling asleep c) waking up during the night d) have
difficulty falling back asleep at night after awakening e) waking up too early in the
morning f) excessive sleepiness during the day
3. Be considered an appropriate surgical candidate.
4. Be older than 21 years of age.
5. Female participants of childbearing potential must have a negative pregnancy test
(urinary or serum beta-HCG).
Exclusion Criteria:
1. Have a known major sleep disorder documented by prior diagnosis, such as: a) sleep
disordered breathing b) narcolepsy c) periodic limb movement disorder d) parasomnias
2. Have any other functional tumors if they have familial Multiple Endocrine Neoplasia
Syndrome 1 or 2 (MEN 1 or MEN 2).
3. Patients with a calcium level greater than 13mg/dL.
4. Patients with recent history of kidney stones.
5. Patients with recent history of pancreatitis
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperparathyroidism
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Intervention(s)
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Behavioral: Polysomnography (PSG)
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Behavioral: Telephone Interview
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Procedure: Parathyroid Surgery
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Primary Outcome(s)
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Total sleep time
[Time Frame: Before and After Intervention]
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Secondary Outcome(s)
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Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT.
[Time Frame: 3 Years]
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Overnight sleep test to measure effect of treatment with parathyroidectomy may have on patients' sleep.
[Time Frame: First set of tests (baseline) will occur within 1-3 weeks prior to intervention/assessment, and the second set of tests will occur 6-8 weeks after the intervention/assessment.]
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Secondary ID(s)
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2007-0220
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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