NCT07921667Not yet recruiting
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Early Detection of Prodromal Relapse Symptoms in Stable Patients With Schizophrenia or Bipolar Disorder Receiving Usual Treatment Through Analysis of Sleep Disturbances Using an Objective Assessment Device
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
The goal of this observational study is to learn whether changes in sleep can help identify early signs of relapse in adults with schizophrenia or bipolar disorder. A relapse means that symptoms return or get worse after a stable period. The study will include 30 adults: 15 with schizophrenia and 15 with bipolar disorder. Participants will have been stable for at least six months and will receive their usual treatment. The main questions are: * Are changes in sleep linked to early signs of relapse? * Are changes in sleep linked to difficulties with everyday activities? Participants will take part for six months. They will: * Sleep at home on a thin mattress topper containing sensors that record sleep patterns. * Meet with a mental health professional at the start and monthly during follow-up. * Answer questions about symptoms, everyday activities, stressful life events, and usual medicines. * Have an additional assessment if the device detects specific changes in sleep or time spent in bed over two consecutive nights. Researchers will compare sleep recordings with symptom assessments to explore whether sleep changes could serve as early warning signs of relapse.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- Feb 2027
- Primary completion date
- Aug 2027
- Lead sponsor
- International University of La Rioja
- Diseases
- Bipolar disorder, Schizophrenia
- NCT number
- NCT07921667
What you commit to
- Study type: Observational
- Planned participants: 30
- From Feb 2027 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Language difficulties, intellectual disability, neurodevelopmental disorders, any form of dementia, or severe traumatic brain injury.
Age
- Age outside the specified range.
Other
- No internet access at home.
Who the study is looking for
- Age between 18 and 60 years.
- Full proficiency in Spanish.
- Diagnosis of schizophrenia or bipolar disorder.
- No hospital admissions during the six months before enrollment.
- Receiving usual treatment for the diagnosed disorder, prescribed by the participant's treating clinician.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital San Pedro | Logroño | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.