Effect of Parathyroidectomy on Sleep
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperparathyroidism |
Procedure: Parathyroid Surgery Behavioral: Telephone Interview Behavioral: Polysomnography (PSG) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study on the Effect of Parathyroidectomy on Sleep |
- Total sleep time [ Time Frame: Before and After Intervention ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Parathyroidectomy + Observation |
Procedure: Parathyroid Surgery
Parathyroid surgery 1-3 weeks after the first PSG.
Behavioral: Telephone Interview
Interview about sleep quality lasting 15-20 minutes.
Behavioral: Polysomnography (PSG)
2 overnight sleep tests Group 1: First PSG 1-3 weeks before surgery + Second PSG 6-8 weeks after surgery Group 2: First PSG 1-3 weeks before phone interview + Second PSG 6-8 weeks after phone interview Other Names:
|
| Observation Alone |
Behavioral: Telephone Interview
Interview about sleep quality lasting 15-20 minutes.
Procedure: Parathyroid Surgery
Parathyroid surgery after completing the second PSG and after the study participation ends.
Behavioral: Polysomnography (PSG)
2 overnight sleep tests Group 1: First PSG 1-3 weeks before surgery + Second PSG 6-8 weeks after surgery Group 2: First PSG 1-3 weeks before phone interview + Second PSG 6-8 weeks after phone interview Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Nancy D. Perrier, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501215 History of Changes |
| Other Study ID Numbers: | 2007-0220 |
| Study First Received: | July 12, 2007 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Primary Hyperparathyroidism PHPT Parathyroidectomy Polysomnogram |
PSG Sleep Quality Interview |
Additional relevant MeSH terms:
|
Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013