HypopituitarismNCT00666068
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
A study testing corticotropin releasing hormone (CRH) in people with Hypopituitarism, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypopituitarism
- What is being tested?
- corticotropin releasing hormone (CRH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Dec 2008
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Complete insufficiency of the anterior pituitary
- Stable hormone substitution for at least 3 months
- Age 18-75 years
Who cannot join
- Hormone excess in the past
- Sleep disorder, e.g. sleep apnea syndrome
- Healthy controls
- Any medication during 6 week prior to study entry
- Shift work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of CRH on the Sleep in Patients With Hypopituitarism
In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.
It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.
To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.
- Conditions
- Hypopituitarism
- Being tested
- corticotropin releasing hormone (CRH), Placebo
- Keywords
- Patients with hypopituitarism
- Medical subject headings
- Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticotropin releasing hormone (CRH)Other
50 µg injected at 2200, 2300, 0000, and 0100
PlaceboOther
injected at 2200, 2300, 0000, and 0100
PlaceboOther
injected at 2200, 2300, 0000, and 0100
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with hypopituitarism
Cross over design: see interventions 1-2 Receives: Other: corticotropin releasing hormone (CRH); Other: Placebo |
| 2 | Placebo comparator | Parallel design:
Healthy controls to be compared with placebo condition in patients with hypopituitarism Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep-EEG variables, conventionally and quantitatively analyzed
Measured: within the first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypopituitarismStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666068
- Sponsor's protocol ID
- L2/2003A
- Status last verified
- May 2011
- First submitted
- 22 Apr 2008
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CRH on the Sleep in Patients With Hypopituitarism
- ClinicalTrials.gov ID
- NCT00666068
- Acronym / sponsor ID
- L2/2003A
- Conditions
- Hypopituitarism
- Keywords
- Patients with hypopituitarism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Apr 2008 (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.
In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.
It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.
To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: corticotropin releasing hormone (CRH), Other: PlaceboPatients with hypopituitarism Cross over design: see interventions 1-2 |
| 2 | Placebo comparator | Other: PlaceboParallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- Complete insufficiency of the anterior pituitary
- Stable hormone substitution for at least 3 months
- Age 18-75 years
Key exclusion criteria (5 listed)
- Hormone excess in the past
- Sleep disorder, e.g. sleep apnea syndrome
- Healthy controls
- Any medication during 6 week prior to study entry
- Shift work
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 |
|---|---|---|
| corticotropin releasing hormone (CRH)50 µg injected at 2200, 2300, 0000, and 0100 | Other | 1 |
| Placeboinjected at 2200, 2300, 0000, and 0100 | Other | 1 |
| Placeboinjected at 2200, 2300, 0000, and 0100 | Other | 2 |
Primary outcome
Sleep-EEG variables, conventionally and quantitatively analyzed
Time frame: within the first month
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 12 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticotropin releasing hormone (CRH) in people with Hypopituitarism, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
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 4 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 12 May 2011. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Sleep-EEG variables, conventionally and quantitatively analyzed (time frame: within the first month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2011.