Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT07143266

Sleep Disorders in Hypothalamic and Pituitary Damage

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-11-18

60

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sleep Disorders in Hypothalamic and Pituitary Damage

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hypothalamic-pituitary dysfunction with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage such as arginine-vasopressin deficiency, severe obesity, hyperphagia, MRI signs of hypothalamic damage, traumatic brain injury, radiotherapy in the sellar region, or brain tumors affecting the hypothalamus
  • Healthy controls matched for BMI, age, and sex
Not Eligible

You will not qualify if you...

  • 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 such as stroke, dementia, or uncontrolled epilepsy with recent seizures
  • Uncontrolled diabetes mellitus
  • Active psychosis
  • Ophthalmological conditions including total blindness, glaucoma, uveitis, visual acuity below 0.6, or eye surgery in the previous 6 months
  • Any acute illness interfering with participation or safety
  • Pregnancy or breastfeeding
  • Refusal or inability to provide informed consent
  • For controls: history of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, or hypopituitarism

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041

Actively Recruiting

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Research Team

A

Anna Aulinas, MD PhD

CONTACT

A

Alejandra Espinosa

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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