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Study Summary
No. 2007-0220:.......Endocrine......Nancy D. Perrier......Surgical Oncology
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Study Summary Title
Study Summary
Number:		2007-0220
Study Title:Pilot Study on the Effect of Parathyroidectomy on Sleep
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Physician New Patient Referral
Name:Nancy D. PerrierPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Surgical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6940
Contact us about clinical trials
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General Information
Disease Group:EndocrineSupported By:UTMDACC Institutional Research Grant
Phase of Study:N/AReturn
Visit:		The 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.
Treatment
Agents:		NoneHome Care:Not Applicable
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Subject participation would involve 12 hours spent in the MDACC Sleep
Laboratory.
Description/
Intervention:		The goal of this clinical research study is to test the possibility of using
nighttime sleep testing in patients with PHPT, in order to measure certain
factors about the quality and amount of their sleep. In addition, researchers
want to use an overnight sleep test in order to measure the effect that
treatment with parathyroidectomy may have on patients' sleep. Researchers also
want to learn if 2 sleep-related questionnaires are an effective way to measure
certain sleep-related factors in patients with PHPT.
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Study Objectives / Outcomes
Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism and has a broad range of clinical manifestations. With respect to the nonclassic, subjective symptoms that have been reported to be associated with PHPT, such as sleep disturbance, neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there is a lack of objective data on the extent to which these symptoms are affected by parathyroidectomy.

There have been reports of improvements in sleep in patients following parathyroidectomy, but these have been based solely on subjective sleep surveys. To date, there are no published studies on objective sleep evaluations of patients with PHPT. The overall goals of this protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT, and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.

It is hypothesized that it will be feasible to evaluate sleep parameters in patients with PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims are:

1.1 Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the primary outcome measure of total sleep time.

1.2 Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the secondary outcome measures of sleep architecture, arousal index, sleep efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.

1.3 Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.
    1.4 Specific Aim 4: To assess the feasibility using a randomized "wait-list"-control design to assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG.
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    Study Status Information
    Study Activation / Registration Date:
    IRB Review and Approval Date:05/25/2007
    Study Type:Observational
    Recruitment Status:Closed
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    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.
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    Links
    Registration Number: NCT00501215
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

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