Effect of Parathyroidectomy on Sleep

NCT00501215 | Completed

• 2 other identifiers: 2007-0220NCI-2010-00658
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Keywords

Primary Hyperparathyroidism; PHPT; Parathyroidectomy; Polysomnogram; PSG; Sleep Quality; Interview

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  Before and After Intervention

Secondary Outcomes (2)

• 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.

• Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT.

  3 Years

Study Arms (2)

Parathyroidectomy + Observation

EXPERIMENTAL

Procedure: Parathyroid Surgery; Behavioral: Telephone Interview; Behavioral: Polysomnography (PSG)

Observation Alone

OTHER

Behavioral: Telephone Interview; Procedure: Parathyroid Surgery; Behavioral: Polysomnography (PSG)

Interventions

Parathyroid Surgery PROCEDURE

Parathyroid surgery 1-3 weeks after the first PSG.

Parathyroidectomy + Observation

Telephone Interview BEHAVIORAL

Interview about sleep quality lasting 15-20 minutes.

Observation Alone; Parathyroidectomy + Observation

Polysomnography (PSG) BEHAVIORAL

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

Also known as: nocturnal polysomnography, sleep study, sleep test, sleep survey, sleep evaluation

Observation Alone; Parathyroidectomy + Observation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Morris GS, Grubbs EG, Hearon CM, Gantela S, Lee JE, Evans DB, Holmes HM, Busaidy NL, Jimenez C, Perrier ND. Parathyroidectomy improves functional capacity in "asymptomatic" older patients with primary hyperparathyroidism: a randomized control trial. Ann Surg. 2010 May;251(5):832-7. doi: 10.1097/SLA.0b013e3181d76bb3.

  PMID: 20395857 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hyperparathyroidism; Hyperparathyroidism, Primary; Sleep Initiation and Maintenance Disorders

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nancy D. Perrier, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: May 25, 2007
• Primary Completion: July 9, 2017
• Study Completion: July 9, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1)