HyperparathyroidismNCT00501215
Effect of Parathyroidectomy on Sleep
A study testing Parathyroid Surgery, Telephone Interview and Polysomnography (PSG) in people with Hyperparathyroidism, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- Parathyroid Surgery, Telephone Interview and Polysomnography (PSG)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2007to 9 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Study on the 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, 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hyperparathyroidism
- Being tested
- Parathyroid Surgery, Telephone Interview, Polysomnography (PSG)
- Keywords
- Primary Hyperparathyroidism, PHPT, Parathyroidectomy, Polysomnogram, PSG, Sleep Quality, Interview
- Medical subject headings
- Hyperparathyroidism, Hyperparathyroidism, Primary, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid SurgeryProcedure or surgery
Parathyroid surgery 1-3 weeks after the first PSG.
Telephone InterviewBehavioural
Interview about sleep quality lasting 15-20 minutes.
Parathyroid SurgeryProcedure or surgery
Parathyroid surgery after completing the second PSG and after the study participation ends.
Polysomnography (PSG)Behavioural
Also called nocturnal polysomnography, sleep study, sleep test, sleep survey
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
| Study group | Role | What they receive |
|---|---|---|
| Parathyroidectomy + Observation | Experimental | Not described Receives: Procedure: Parathyroid Surgery; Behavioral: Telephone Interview; Behavioral: Polysomnography (PSG) |
| Observation Alone | Other | Not described Receives: Behavioral: Telephone Interview; Procedure: Parathyroid Surgery; Behavioral: Polysomnography (PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Measured: Before and After Intervention
Secondary outcomes (2)
Overnight sleep test to measure effect of treatment with parathyroidectomy may have on patients' sleep.
Measured: 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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study start25 May 2007
- Primary completion9 Jul 2017
- Study completion9 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy D. Perrier, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501215
- Sponsor's protocol ID
- 2007-0220
- Other IDs
- NCI-2010-00658
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2007
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20395857
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of Parathyroidectomy on Sleep
- ClinicalTrials.gov ID
- NCT00501215
- Acronym / sponsor ID
- 2007-0220
- Conditions
- Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism, PHPT, Parathyroidectomy, Polysomnogram, PSG, Sleep Quality, Interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 May 2007 (actual)
- Primary completion
- 9 Jul 2017 (actual)
- Study completion
- 9 Jul 2017 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parathyroidectomy + Observation | Experimental | Procedure: Parathyroid Surgery, Behavioral: Telephone Interview, Behavioral: Polysomnography (PSG) |
| Observation Alone | Other | Behavioral: Telephone Interview, Procedure: Parathyroid Surgery, Behavioral: Polysomnography (PSG) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parathyroid SurgeryParathyroid surgery 1-3 weeks after the first PSG. | Procedure or surgery | Parathyroidectomy + Observation |
| Telephone InterviewInterview about sleep quality lasting 15-20 minutes. | Behavioural | Observation Alone, Parathyroidectomy + Observation |
| Parathyroid SurgeryParathyroid surgery after completing the second PSG and after the study participation ends. | Procedure or surgery | Observation Alone |
| Polysomnography (PSG)Also: nocturnal polysomnography, sleep study, sleep test, sleep survey2 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 | Behavioural | Observation Alone, Parathyroidectomy + Observation |
Primary outcome
Total sleep time
Time frame: Before and After Intervention
2 secondary outcomes
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.
Effectiveness of 2 sleep-related questionnaires to measure certain sleep-related factors in patients with PHPT.
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 20395857Morris 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy D. Perrier, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroid Surgery, Telephone Interview and Polysomnography (PSG) in people with Hyperparathyroidism, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (time frame: Before and After Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.