Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT07143266
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Disorders in Hypothalamic and Pituitary Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}], 'ancestors': [{'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sleep disorders in patients with hypothalamic and pituitary damage compared to healthy controls', 'timeFrame': 'From enrollment to completion of the assessments at 3 months', 'description': 'Prevalence (%) of patients with sleep disorders (assessed by objective and subjective measures of sleep):\n\n* Impaired sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) and nocturnal polisomnography (PSG)\n* Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS)\n* Obstructive Sleep Apnea (OSA) assessed by Berlin Questionnaire (BQ), Stop- BANG score risk and PSG\n* Insomnia assessed by Severity Index (ISI).\n* Daytime Sleepiness assessed by Multiple Sleep Latency Test (MSLT)'}], 'secondaryOutcomes': [{'measure': 'Saliva oxytocin concentrations in patients compared to controls', 'timeFrame': 'From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)', 'description': '* Oxytocin samples will be collected at 6:00 a.m., 12:00 p.m., 6:00 p.m., and 11:00 p.m.\n* Correlations between oxytocin concentrations and sleep disorders will be performed.'}, {'measure': 'Urine 6-sulfametoxymelatonin concentrations in patients compared to controls', 'timeFrame': 'From day 1 and day 2 of the objective sleep assessments (polisomnography and MSLT)', 'description': '* Samples will be collected at 9:00 p.m., 6:00 a.m., 12:00 p.m., and 5:00 p.m in urine.\n* Correlations between 6-sulfametoxymelatonin concentrations and sleep disorders will be performed.'}, {'measure': 'Prevalence of Brain structural and perfusion abnormalities using Magnetic Resonance Imaging in patients compared to controls', 'timeFrame': 'From enrollment to completion of the assessment at 3 months', 'description': '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.\n\nBrain structural and perfusion abnormalities will be correlated with sleep measures'}, {'measure': 'Prevalence of glucose brain metabolism abnormalities using Fluorodeoxyglucose Positron Emission Tomography in patients and controls', 'timeFrame': 'From enrollment to completion of the assessment at 3 months', 'description': 'Glucose brain metabolism will be quantified at ROI. Brain glucose metabolism will be correlated with sleep measures'}, {'measure': 'Prevalence of patients with neuroophthalmological damage (in patients with HPD only) assessed by an expert neuro-ophthalmologist', 'timeFrame': 'Baseline', 'description': 'Prevalence (%) of patients with the following:\n\n* Impaired visual actuity\n* Impaired intraocular pressure using applanation tonometry\n* Impaired macular volume and retinal ganglion cell layer using standard Automated 24-2 Humphrey perimetry and spectral- domain optical coherence tomography (SD- OCT).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Disorder', 'Oxytocin deficiency', 'Hypopituitarism', 'Hypothalamic damage'], 'conditions': ['Hypopituitarism', 'Sleep Wake Disorders', 'Hypothalamic Diseases', 'Oxytocin Deficiency']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* Healthy controls matched for BMI, age, and sex.\n\nExclusion Criteria:\n\n* Poor control of hormonal deficiencies in the previous 6 months.\n* Use of new psychoactive drugs in the last 3 months or occasional use.\n* Clinically significant liver, lung, kidney, and cardiovascular disease.\n* Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).\n* Uncontrolled diabetes mellitus.\n* Active psychosis.\n* Ophthalmology: total blindness, Glaucoma, uveitis, visual acuity \\<0.6, or eye surgery in the previous 6 months.\n* Any acute illness that the investigator determines may interfere with study participation or safety.\n* Pregnancy or breastfeeding.\n* Patients who refuse or are unable to provide written informed consent.\n* In controls: presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, and history of hypopituitarism.'}, 'identificationModule': {'nctId': 'NCT07143266', 'acronym': 'SDHPD', 'briefTitle': 'Sleep Disorders in Hypothalamic and Pituitary Damage', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage', 'orgStudyIdInfo': {'id': 'IIBSP-SUE-2024-36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hypopituitarism and hypothalamic damage with or without vasopressin deficiency', 'description': 'Differences between those patients with vasopressin deficiency (AVP-D) and those without AVP-D will be analyzed.', 'interventionNames': ['Other: This is an observational study. No drugs will be administered']}, {'label': 'Healthy controls', 'description': 'Similar age, and BMI than the study group (patients with hypopituitarism) and matched by sex.', 'interventionNames': ['Other: This is an observational study. No drugs will be administered']}], 'interventions': [{'name': 'This is an observational study. No drugs will be administered', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Healthy controls', 'Patients with hypopituitarism and hypothalamic damage with or without vasopressin deficiency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Anna Aulinas, MD PhD', 'role': 'CONTACT', 'email': 'aaulinas@santpau.cat', 'phone': '+34932919000', 'phoneExt': '7917'}, {'name': 'Alejandra Espinosa', 'role': 'CONTACT', 'email': 'aespinosag@santpau.cat', 'phone': '+34932919000', 'phoneExt': '7634'}, {'name': 'Anna Aulinas, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Anna Aulinas, MD PhD', 'role': 'CONTACT', 'email': 'aaulinas@santpau.cat', 'phone': '+34932919000', 'phoneExt': '7971'}, {'name': 'Alejandra Espinosa', 'role': 'CONTACT', 'email': 'aespinosag@santpau.cat', 'phone': '+34932919000', 'phoneExt': '7634'}], 'overallOfficials': [{'name': 'Anna Aulinas, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}