Pilot Study on the Effect of Parathyroidectomy on Sleep
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Total sleep time
Study Overview
Brief Summary
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.
Detailed Description
Screening Test:
To be eligible to take part in this study, women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test.
Study Groups:
If you are found to be eligible to take part in this study and you agree to take part, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal chance that you will be assigned to either group. One group (the 'Surgical' Group) will receive the parathyroid surgery and "observation" (the review of blood tests by the study doctor) during the course of the study. The other group (the 'Observation' Group) will receive observation alone, and then surgery after their study participation ends.
All participants will have 2 overnight sleep tests (called "polysomnograms" -- PSGs) and a telephone interview on sleep quality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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
- •Be considered an appropriate surgical candidate.
- •Be older than 21 years of age.
- •Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG).
Exclusion Criteria
- •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
- •Have any other functional tumors if they have familial Multiple Endocrine Neoplasia Syndrome 1 or 2 (MEN 1 or MEN 2).
- •Patients with a calcium level greater than 13mg/dL.
- •Patients with recent history of kidney stones.
- •Patients with recent history of pancreatitis
Arms & Interventions
Parathyroidectomy + Observation
Intervention: Parathyroid Surgery (Procedure)
Parathyroidectomy + Observation
Intervention: Telephone Interview (Behavioral)
Parathyroidectomy + Observation
Intervention: Polysomnography (PSG) (Behavioral)
Observation Alone
Intervention: Telephone Interview (Behavioral)
Observation Alone
Intervention: Parathyroid Surgery (Procedure)
Observation Alone
Intervention: Polysomnography (PSG) (Behavioral)
Outcomes
Primary Outcomes
Total sleep time
Time Frame: Before and After Intervention
Secondary Outcomes
- Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT.(3 Years)
- 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.)