Status:
RECRUITING
Sleep Disorders in Hypothalamic and Pituitary Damage
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Hypopituitarism
Sleep Wake Disorders
Eligibility:
All Genders
18-70 years
Brief 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 fun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07143266
Start Date
September 1 2025
End Date
December 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041