Trial Information

Pilot Study on the Effect of Parathyroidectomy on Sleep

Screening Test:

To be eligible to take part in this study, women who are able to have children must have a
negative blood (about 1 teaspoon) pregnancy test.

Study Groups:

If you are found to be eligible to take part in this study and you agree to take part, you
will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal
chance that you will be assigned to either group. One group (the 'Surgical' Group) will
receive the parathyroid surgery and "observation" (the review of blood tests by the study
doctor) during the course of the study. The other group (the 'Observation' Group) will
receive observation alone, and then surgery after their study participation ends.

All participants will have 2 overnight sleep tests (called "polysomnograms" -- PSGs) and a
telephone interview on sleep quality.

The Surgical Group will have their first PSG, and then 1-3 weeks later their surgery and a
telephone interview will be performed. (For the surgery, a separate informed consent form
will be signed that will describe the procedure in detail.) About 6-8 weeks after surgery,
a second PSG will be performed.

The Observation Group will have their first PSG, and then a telephone interview 1-3 weeks
later. At 6-8 weeks after the interview, a second PSG will be performed. The Observation
Group participants will be offered to have their parathyroid surgery soon after they
complete their second PSG (after their 7-11 week participation in this study is over).

Sleep Quality Interview:

For the telephone interview, a research staff member will call you at home to ask you to
discuss 6 questions about the quality of your sleep. It should take about 15-20 minutes.

Polysomnography:

A PSG is a standard test for evaluating sleep. However, patients with PHPT do not routinely
receive PSGs as part of their standard care.

PSGs use many measurements made while the participant is asleep. Sensors on the body record
information about a person's sleep stages, body position, blood oxygen levels, breathing,
muscle tone, heart rate, snoring, and general sleep behavior.

Electroencephalogram (EEG) sensors will be placed on your scalp and face in order to measure
what 'stage' of sleep you are in. Electrocardiogram (ECG) sensors will be placed on your
chest to monitor your heartbeat. A small probe will rest just inside your nostrils in order
to measure your breathing and airflow. A snoring sensor will be taped on your neck.
Elastic straps will be placed around your chest and abdomen (midsection), which will measure
your breathing effort. Sensors will be placed on both of your shins in order to measure
your leg movements. A sensor will be taped onto your fingertip in order to measure your
blood oxygen levels.

Audio and video recordings will be made of your sleep in order to monitor your body
positions and to record any sleep disturbances and/or restless movements that may occur.

For both of the PSGs, you will arrive at the M. D. Anderson Sleep Center at about 7:30 p.m.
You will complete a questionnaire about your sleep the night before and your activities
during that day. You will also complete a questionnaire that asks about any 'dozing off'
habits you may have. It should take about 10-15 minutes to complete the 2 questionnaires.
You will be taken to a sleep room, which will be quiet and darkened. A registered PSG
technologist will place the sensors on your body. You will be allowed to sleep until your
usual wake-up time, as noted on your sleep diary. Soon after you wake up, the sensors will
be removed. You will complete a third questionnaire about your night's sleep. This last
questionnaire should take about 5-10 minutes to complete. You will be able to leave shortly
after completing the questionnaire.

If you normal sleep during the day, the study staff will arrange the sleep study to happen
around your usual sleeping and waking times.

Sleep Diaries:

For the 7 days before each PSG, you will complete a sleep diary. In the diary, you will
record information about the quality and amount of your sleep. You will bring the sleep
diary to the Sleep Center on the days of your PSGs.

Biomarker Testing:

Blood (about 4 teaspoons each time) will be drawn earlier in the day of your PSG, before you
have the PSG performed. This blood will be used to measure certain biomarkers that will be
compared with the results of your PSGs and questionnaires. These biomarkers include the
levels of calcium, parathyroid hormone (PTH), and vitamin D in your blood.

Possible Crossover to Surgical Group:

If you are in the Observation Group and your blood tests show very high calcium levels, you
will be offered parathyroid surgery as soon as reasonably possible.

Also, if you are in the Observation Group and you start experiencing worsening symptoms that
may mean kidney stones (such as abdominal pain and/or blood in the urine) or inflammation of
the pancreas (such as abdominal pain, nausea, vomiting, fever, and/or chills), your
condition will be evaluated and treated. You will then be offered parathyroid surgery as
soon as reasonably possible. At 6-8 weeks after your parathyroid surgery, you will have
your second PSG.

Sleep Test Results:

You will be able to receive a copy of your PSG results. If the results show any sleep
disorders and/or other medical disorders, you will referred for standard treatment.

The results of the PSG will not affect your PHPT treatment in any way.

Length of Study:

After your second PSG, your participation in this study will be over.

This is an investigational study. Using PSGs for this purpose in patients with PHPT is
considered experimental.

Up to 12 patients will take part in this study. All will be enrolled at M. D. Anderson.