Effect of Parathyroidectomy on Sleep

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501215
First received: July 12, 2007
Last updated: January 27, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Total sleep time [ Time Frame: Before and After Intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • nocturnal polysomnography
  • sleep study
  • sleep test
  • sleep survey
  • sleep evaluation
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:
  • nocturnal polysomnography
  • sleep study
  • sleep test
  • sleep survey
  • sleep evaluation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501215

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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 27, 2014
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 April 16, 2014