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NCT00501215 · ClinicalTrials.gov registry record · NA
Effect of Parathyroidectomy on Sleep
A NA study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT00501215: Completed NA study, sponsored by M.D. Anderson Cancer Center.
NCT00501215 is a NA study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501215, a NA study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Telephone Interview
- PROCEDURE Parathyroid Surgery
- BEHAVIORAL Polysomnography (PSG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-05-25 |
| Est. Completion | 2017-07-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00501215
The ClinicalTrials.gov registry entry for NCT00501215 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Telephone Interview is the first listed.
NCT00501215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00501215 about?
NCT00501215 is a clinical study titled "Effect of Parathyroidectomy on Sleep". 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...
What is the current status of trial NCT00501215?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2007-05-25. Estimated completion is 2017-07-09.
What interventions are being tested in trial NCT00501215?
The interventions under investigation include: Telephone Interview (BEHAVIORAL), Parathyroid Surgery (PROCEDURE), Polysomnography (PSG) (BEHAVIORAL).
Who is sponsoring clinical trial NCT00501215?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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