Sleep problems after hypothalamus or pituitary damage
Official title: Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage
Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07143266 · Data updated 2026-11-12
This study will test how common sleep problems are and whether low oxytocin links to poor sleep in people with hypothalamic or pituitary damage.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | May 2027 |
| Study ends | December 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07143266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with hypothalamic-pituitary dysfunction who have at least one pituitary hormone deficiency plus clinical signs of hypothalamic damage (for example AVP deficiency, severe obesity/hyperphagia, relevant MRI findings, brain injury, or prior sellar radiotherapy/tumor) are ideal candidates, and the study also enrolls matched healthy volunteers.
✕Probably not a fit
People with poorly controlled hormonal deficiencies, recent use of new psychoactive drugs, major organ failure, neurological diseases affecting brain function, uncontrolled diabetes, active psychosis, significant ophthalmologic problems, or recent eye surgery are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study comparing people with hypothalamic-pituitary dysfunction (HPD) to healthy volunteers matched for age, sex, and BMI to define how often sleep disorders occur in HPD. Researchers will measure sleep quality and related clinical features alongside oxytocin levels and other endocrine or imaging markers to explore mechanisms. No drugs are given; the goal is to link biochemical and clinical findings to sleep outcomes. Findings aim to guide prevention and targeted treatment strategies for sleep problems in this population.
Why it matters
Potential benefit: If successful, this could help clinicians identify sleep problems earlier in people with HPD and point toward oxytocin-related or other targeted approaches to improve sleep and quality of life.
How similar studies have gone: Some preclinical and small human studies suggest oxytocin can affect sleep, but applying this specifically to patients with hypothalamic-pituitary damage is largely novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where it's running
-
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Anna Aulinas, MD PhD — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study coordinator: Anna Aulinas, MD PhD
- Email: aaulinas@santpau.cat
- Phone: +34932919000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.