Sleep and body temperature as markers of progression of Alzheimer's disease in Down syndrome.
Key facts
- Where
- Barcelona, SpanyolországSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
- Trial code
- EU 2023-506609-21-00
- Record updated
- 2026. október 20.
- Original description
Study the relationship between sleep disorders and circadian variations in body temperature as risk factors for the progression of Alzheimer's disease in Down's syndrome.Read full original descriptionShow less
Sleep and Temperature Disturbance as risk factors for Alzheimer's Disease in Down Syndrome: a Longitudinal Study.
Study the relationship between sleep disorders and circadian variations in body temperature as risk factors for the progression of Alzheimer's disease in Down's syndrome.
Inclusion: Subjects with Down syndrome of both sexes between 40 and 60 years; With a degree of intellectual disability that allows completing the CAMCOG cognitive battery.mild or moderate; Diagnosis of Down syndrome confirmed by karyotyping; Patients with good general health.
Exclusion: Current use of sedatives/hypnotics, stimulants, antipsychotics, gabapentin, pregabalin, tricyclic antidepressants and trazodone, or other psychoactive medications that may alter slow wave sleep (SWS) or body temperature; Use of new psychoactive drugs in the three months prior to the study; Any significant unstable medical or psychiatric condition or disease; Psychiatric illnesses that may affect cognition, such as bipolar disorder or schizophrenia, or the use of medications or substance abuse; Gastrointestinal conditions that may present a risk of bowel wall protrusion; Medical conditions including uncontrolled pulmonary or cardiac disease, untreated hypothyroidism, brain tumors, stroke, head trauma and hydrocephalus. It should be noted that thyroid status will be assessed by TSHs and Free T3 and T4 at the time of medical screening; Inability to give informed consent; Common contraindications for MRI (claustrophobia, pacemaker, aneurysm clip, etc.). aneurysm clip, etc.); Pregnancy; Irregular sleep cycles, extremely long or short total sleep duration and extreme unstable circadian mismatch (3 months or more).