Effect of Parathyroidectomy on Sleep - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00501215

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)

Drug Information available for: Parathyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Pilot Study on the Effect of Parathyroidectomy on Sleep

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

Primary Outcome Measures:

To test the possibility of using nighttime sleep testing in patients with PHPT, in order to measure certain factors about the quality and amount of their sleep. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To use an overnight sleep test in order to measure the effect that treatment with parathyroidectomy may have on patients' sleep. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To learn if 2 sleep-related questionnaires are an effective way to measure certain sleep-related factors in patients with PHPT. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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
2: No Intervention 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

Arms

Assigned Interventions

1: 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

2: No Intervention

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

Show Detailed Description

Eligibility

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

Criteria

Inclusion:

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:

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

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

Contacts

Contact: Nancy D. Perrier, MD

713-792-6940

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Nancy D. Perrier, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Nancy D. Perrier, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Nancy D. Perrier, MD/Associate Professor )
Study ID Numbers:	2007-0220
Study First Received:	July 12, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00501215
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Primary Hyperparathyroidism
PHPT
Parathyroidectomy
Polysomnogram

PSG
Sleep Quality
Interview

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism
Hyperparathyroidism, primary

Endocrine System Diseases
Endocrinopathy
Hyperparathyroidism, Primary

ClinicalTrials.gov processed this record on January 14, 2009