Actively Recruiting
Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With 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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating sleep disorders in patients with hypothalamic and pituitary damage (HPD), conditions that affect vital functions including sleep-wake cycles. The study aims to identify how common sleep disorders are in these patients, understand the role of oxytocin in sleep quality, and explore the underlying mechanisms associated with sleep problems in HPD. This multidisciplinary research combines neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine, and neuro-ophthalmology to improve knowledge and treatment options for affected individuals. This observational study compares patients with HPD, some with vasopressin deficiency, to healthy controls matched by age, sex, and body mass index. Participants undergo objective sleep assessments including actigraphy, polysomnography, and the Multiple Sleep Latency Test, as well as subjective sleep evaluations via questionnaires. Additional evaluations include brain imaging with MRI and PET-CT, ophthalmological exams, and hormone level testing from blood and urine samples. No drugs or interventions are administered during the study. Participants will be assessed over a period of up to three months, during which data on sleep quality, oxytocin and melatonin levels, brain structure and metabolism, and neuro-ophthalmological status are collected. Researchers will measure the prevalence of sleep disorders and examine brain and hormone abnormalities to understand their impact on health and quality of life in HPD patients. This comprehensive approach aims to identify new strategies for prevention and treatment of sleep disorders related to hypothalamic and pituitary damage.
CONDITIONS
Brief Title
Sleep Disorders in Hypothalamic and Pituitary Damage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hypothalamic-pituitary dysfunction having at least one pituitary hormone deficiency and one clinical sign of hypothalamic damage such as vasopressin deficiency, severe obesity, or hyperphagia
- MRI suggestive of hypothalamic damage, history of traumatic brain injury, radiotherapy in the sellar region, or brain tumors affecting the hypothalamus
- Healthy controls matched by body mass index, age, and sex
- Adults aged 18 to 70 years
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, or cardiovascular disease
- Any neurological condition affecting brain function such as stroke, dementia, or uncontrolled epilepsy with recent seizures
- Uncontrolled diabetes mellitus
- Active psychosis
- Eye conditions including total blindness, glaucoma, uveitis, visual acuity below 0.6, or eye surgery in the previous 6 months
- Any acute illness that may interfere with participation or safety
- Pregnancy or breastfeeding
- Inability or refusal to provide written informed consent
- For controls: history of brain or pituitary tumor, radiation involving hypothalamus or pituitary, or hypopituitarism history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo objective sleep evaluations including actigraphy, polysomnography, and MSLT, as well as neuroimaging (MRI and PET-CT), ophthalmological, and hormone evaluations to assess sleep disorders and brain abnormalities.
2 visits for objective sleep assessments and multiple assessments for imaging and evaluations
Duration - Up to 3 months
Participants' prevalence of sleep disorders and brain abnormalities are monitored and analyzed over the assessment period.
Follow-up assessments may occur during this period
Trial Site Locations
Total: 1 location
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
Research Team
A
Anna Aulinas, MD PhD
A
Alejandra Espinosa
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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