HypopituitarismSDHPDNCT07143266
Sleep Disorders in Hypothalamic and Pituitary Damage
An observational study of Hypopituitarism and Sleep Wake Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Hypothalamus has a key role in multiple vital functions, including regulation of sleep-wake cycles. Oxytocin (OT), a neurohormone synthetized in the hypothalamus, has a wide range of physiological functions, including a putative role in improving sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypopituitarism, Sleep Wake Disorders, Hypothalamic Diseases
- What is being tested?
- This is an observational study. No drugs will be administered
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be recruited from the Research Center for Pituitary Diseases and the Neurosurgery Department at the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Who may be able to join
- Patients with hypothalamic-pituitary dysfunction (HPD) with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage (e.g., arginine-vasopressin deficiency (AVP-D) and/or severe obesity and/or hyperphagia; MRI suggestive of hypothalamic damage; traumatic brain injury; radiotherapy in the sellar region and/or brain tumors affecting the hypothalamus).
- Healthy controls matched for BMI, age, and sex.
Who cannot join
- Poor control of hormonal deficiencies in the previous 6 months.
- Use of new psychoactive drugs in the last 3 months or occasional use.
- Clinically significant liver, lung, kidney, and cardiovascular disease.
- Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).
- Uncontrolled diabetes mellitus.
- Active psychosis.
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- Ophthalmology: total blindness, Glaucoma, uveitis, visual acuity <0.6, or eye surgery in the previous 6 months.
- Any acute illness that the investigator determines may interfere with study participation or safety.
- Pregnancy or breastfeeding.
- Patients who refuse or are unable to provide written informed consent.
- In controls: presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, and history of hypopituitarism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Anna Aulinas, MD PhD, +34932919000 ext. 7917, aaulinas@santpau.cat
Alejandra Espinosa, +34932919000 ext. 7634, aespinosag@santpau.cat
About this study
Official title: Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage
Hypothalamus has a key role in multiple vital functions, including regulation of sleep-wake cycles. Oxytocin (OT), a neurohormone synthetized in the hypothalamus, has a wide range of physiological functions, including a putative role in improving sleep quality. Hypothalamic and pituitary damage (HPD) is associated with a clinically relevant OT deficient state and multiple and severe comorbidities including poor sleep quality, that have a well-known negative impact on general health and quality of life (QoL). Several factors may coexist in the pathophysiology of sleep disorders (SD) in HPD and SD might be a keystone in the persistence of some of the comorbidities observed in HPD. Therefore, appropriate identification and understanding of the mechanisms contributing to SD in HPD is mandatory to choose adequate preventive strategies and treatment. This project is aimed to (1) identify the prevalence of SD in HPD, (2) to determine OT role in sleep quality and (3) to identify potential mechanisms and mediators of sleep quality and their associations with clinical outcomes in patients with HPD with the ultimate goal of identifying preventive and therapeutic targets. We will use a controlled cross-sectional design of patients with HPD and sex-, BMI-, age- matched controls and an innovative cross-disciplinary approach bridging neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine and neuroophthalmology disciplines to learn about the prevalence of SD in HPD and to disentangle the underpinning mechanisms behind SDs in HPD. The results of this project will be an extremely important step towards optimizing therapy for patients with HPD who have higher mortality and poor QoL despite appropriate hormone replacement therapy.
- Being tested
- This is an observational study. No drugs will be administered
- Keywords
- Sleep Disorder, Oxytocin deficiency, Hypopituitarism, Hypothalamic damage
- Medical subject headings
- Hypopituitarism, Sleep Wake Disorders, Hypothalamic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study. No drugs will be administeredOther
Data from objective sleep evaluation (actigraphy, polisomnography and MLST), subjective sleep evaluation (questionnaires), neuroimaging (MRI and PET-CT), ophthalmological evaluation and hormone evaluation (urine and blood) will be collected in a cross-sectional manner, without performing any additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypopituitarism and hypothalamic damage with or without vasopressin deficiency | Differences between those patients with vasopressin deficiency (AVP-D) and those without AVP-D will be analyzed. Receives: Other: This is an observational study. No drugs will be administered | |
| Healthy controls | Similar age, and BMI than the study group (patients with hypopituitarism) and matched by sex. Receives: Other: This is an observational study. No drugs will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disorders in patients with hypothalamic and pituitary damage compared to healthy controls
Prevalence (%) of patients with sleep disorders (assessed by objective and subjective measures of sleep):
- Impaired sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) and nocturnal polisomnography (PSG)
- Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS)
- Obstructive Sleep Apnea (OSA) assessed by Berlin Questionnaire (BQ), Stop- BANG score risk and PSG
- Insomnia assessed by Severity Index (ISI).
- Daytime Sleepiness assessed by Multiple Sleep Latency Test (MSLT)
Measured: From enrollment to completion of the assessments at 3 months
Secondary outcomes (5)
Saliva oxytocin concentrations in patients compared to controls
- Oxytocin samples will be collected at 6:00 a.m., 12:00 p.m., 6:00 p.m., and 11:00 p.m.
- Correlations between oxytocin concentrations and sleep disorders will be performed.
Measured: From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)
Urine 6-sulfametoxymelatonin concentrations in patients compared to controls
- Samples will be collected at 9:00 p.m., 6:00 a.m., 12:00 p.m., and 5:00 p.m in urine.
- Correlations between 6-sulfametoxymelatonin concentrations and sleep disorders will be performed.
Measured: From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)
Prevalence of Brain structural and perfusion abnormalities using Magnetic Resonance Imaging in patients compared to controls
ROI related to sleep (e.g thalamus, cortex, amygdala) will be defined; gray matter hyperintensities will be quantified from the FLAIR image; DTI will calculate diffusor tensor parameters (FA, mean, axial and radial diffusivity) across the whole brain.
Brain structural and perfusion abnormalities will be correlated with sleep measures
Measured: From enrollment to completion of the assessment at 3 months
Prevalence of glucose brain metabolism abnormalities using Fluorodeoxyglucose Positron Emission Tomography in patients and controls
Glucose brain metabolism will be quantified at ROI. Brain glucose metabolism will be correlated with sleep measures
Measured: From enrollment to completion of the assessment at 3 months
Prevalence of patients with neuroophthalmological damage (in patients with HPD only) assessed by an expert neuro-ophthalmologist
Prevalence (%) of patients with the following:
- Impaired visual actuity
- Impaired intraocular pressure using applanation tonometry
- Impaired macular volume and retinal ganglion cell layer using standard Automated 24-2 Humphrey perimetry and spectral- domain optical coherence tomography (SD- OCT).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Aulinas, MD PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143266
- Sponsor's protocol ID
- IIBSP-SUE-2024-36
- Acronym
- SDHPD
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage
- ClinicalTrials.gov ID
- NCT07143266
- Acronym / sponsor ID
- SDHPD / IIBSP-SUE-2024-36
- Keywords
- Sleep Disorder, Oxytocin deficiency, Hypopituitarism, Hypothalamic damage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- 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.
Hypothalamus has a key role in multiple vital functions, including regulation of sleep-wake cycles. Oxytocin (OT), a neurohormone synthetized in the hypothalamus, has a wide range of physiological functions, including a putative role in improving sleep quality. Hypothalamic and pituitary damage (HPD) is associated with a clinically relevant OT deficient state and multiple and severe comorbidities including poor sleep quality, that have a well-known negative impact on general health and quality of life (QoL). Several factors may coexist in the pathophysiology of sleep disorders (SD) in HPD and SD might be a keystone in the persistence of some of the comorbidities observed in HPD. Therefore, appropriate identification and understanding of the mechanisms contributing to SD in HPD is mandatory to choose adequate preventive strategies and treatment. This project is aimed to (1) identify the prevalence of SD in HPD, (2) to determine OT role in sleep quality and (3) to identify potential mechanisms and mediators of sleep quality and their associations with clinical outcomes in patients with HPD with the ultimate goal of identifying preventive and therapeutic targets. We will use a controlled cross-sectional design of patients with HPD and sex-, BMI-, age- matched controls and an innovative cross-disciplinary approach bridging neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine and neuroophthalmology disciplines to learn about the prevalence of SD in HPD and to disentangle the underpinning mechanisms behind SDs in HPD. The results of this project will be an extremely important step towards optimizing therapy for patients with HPD who have higher mortality and poor QoL despite appropriate hormone replacement therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hypopituitarism and hypothalamic damage with or without vasopressin deficiency | – | Other: This is an observational study. No drugs will be administeredDifferences between those patients with vasopressin deficiency (AVP-D) and those without AVP-D will be analyzed. |
| Healthy controls | – | Other: This is an observational study. No drugs will be administeredSimilar age, and BMI than the study group (patients with hypopituitarism) and matched by sex. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited from the Research Center for Pituitary Diseases and the Neurosurgery Department at the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Key inclusion criteria (2 listed)
- Patients with hypothalamic-pituitary dysfunction (HPD) with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage (e.g., arginine-vasopressin deficiency (AVP-D) and/or severe obesity and/or hyperphagia; MRI suggestive of hypothalamic damage; traumatic brain injury; radiotherapy in the sellar region and/or brain tumors affecting the hypothalamus).
- Healthy controls matched for BMI, age, and sex.
Key exclusion criteria (11 listed)
- Poor control of hormonal deficiencies in the previous 6 months.
- Use of new psychoactive drugs in the last 3 months or occasional use.
- Clinically significant liver, lung, kidney, and cardiovascular disease.
- Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| This is an observational study. No drugs will be administeredData from objective sleep evaluation (actigraphy, polisomnography and MLST), subjective sleep evaluation (questionnaires), neuroimaging (MRI and PET-CT), ophthalmological evaluation and hormone evaluation (urine and blood) will be collected in a cross-sectional manner, without performing any additional intervention. | Other | Healthy controls, Patients with hypopituitarism and hypothalamic damage with or without vasopressin deficiency |
Primary outcome
Prevalence of sleep disorders in patients with hypothalamic and pituitary damage compared to healthy controls
Time frame: From enrollment to completion of the assessments at 3 months
Prevalence (%) of patients with sleep disorders (assessed by objective and subjective measures of sleep): * Impaired sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) and nocturnal polisomnography (PSG) * Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS) * Obstructive Sleep Apnea (OSA) assessed by Berlin Questionnaire (BQ), Stop- BANG score risk and PSG * Insomnia assessed by Severity Index (ISI). * Daytime Sleepiness assessed by Multiple Sleep Latency Test (MSLT)
5 secondary outcomes
Saliva oxytocin concentrations in patients compared to controls
Time frame: From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)
Urine 6-sulfametoxymelatonin concentrations in patients compared to controls
Time frame: From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)
Prevalence of Brain structural and perfusion abnormalities using Magnetic Resonance Imaging in patients compared to controls
Time frame: From enrollment to completion of the assessment at 3 months
Prevalence of glucose brain metabolism abnormalities using Fluorodeoxyglucose Positron Emission Tomography in patients and controls
Time frame: From enrollment to completion of the assessment at 3 months
Prevalence of patients with neuroophthalmological damage (in patients with HPD only) assessed by an expert neuro-ophthalmologist
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
Anna Aulinas, MD PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypopituitarism and Sleep Wake Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Aulinas, MD PhD (+34932919000 ext. 7971, aaulinas@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disorders in patients with hypothalamic and pituitary damage compared to healthy controls (time frame: From enrollment to completion of the assessments at 3 months). 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 18 Nov 2025.