Hyperparathyroidism Clinical Trial
Official title:
Pilot Study on the Effect of Parathyroidectomy on Sleep
Verified date | July 2017 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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:
Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to
evaluate the primary outcome measure of total sleep time.
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.
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.
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | July 9, 2017 |
Est. primary completion date | July 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total sleep time | Before and After Intervention | ||
Secondary | Overnight sleep test to measure effect of treatment with parathyroidectomy may have on patients' sleep. | 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. | ||
Secondary | Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT. | 3 Years |
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