An observational study in Bipolar Disorder (BD) and SCHIZOPHRENIA 1 (Disorder), sponsored by International University of La Rioja. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by International University of La Rioja · Observational
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:
Participants will take part for six months. They will:
Researchers will compare sleep recordings with symptom assessments to explore whether sleep changes could serve as early warning signs of relapse.
DESCANT is a prospective, longitudinal observational study examining the relationship between objectively measured sleep disturbances and early symptoms of relapse in clinically stable adults with schizophrenia or bipolar disorder receiving usual treatment.
Sleep data will be collected in participants' homes using a prototype sensor-equipped mattress topper. Recorded variables will include sleep duration, awakenings, movements, and time spent in bed. Individual baseline patterns will provide a reference for identifying subsequent changes.
Clinical assessments will take place at baseline, monthly during follow-up, and at the end of the six-month observation period. An additional assessment will be triggered when the device detects a change of at least 20% from the participant's usual sleep duration or time spent in bed over two consecutive nights. These assessments will examine whether the detected changes coincide with early psychiatric symptom worsening.
Symptoms in participants with schizophrenia will be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants with bipolar disorder will be assessed using the Young Mania Rating Scale (YMRS) and the Hamilton Depression Rating Scale (HDRS). Functioning will be assessed using the Functioning Assessment Short Test (FAST). Stressful life events will be recorded using the Social Readjustment Rating Scale (SRRS). Sociodemographic characteristics and usual psychotropic medication will also be recorded.
The analysis will examine relationships between changes in sleep patterns, psychiatric symptoms, and functioning over time. Stressful life events will be considered as a potential influencing factor. The study aims to generate preliminary evidence about whether home-based sleep measurements can help identify early signs of relapse.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →International University of La Rioja is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will comprise 30 adults aged 18 to 60 years with a diagnosis of schizophrenia (15 participants) or bipolar disorder (15 participants). Participants will be recruited through mental health services and associations supporting people with mental health conditions. They will be receiving usual treatment prescribed by their treating clinician and will have had no hospital admissions during the preceding six months. Participants will undergo home-based sleep monitoring and clinical follow-up for six months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults with a diagnosis of schizophrenia who have been clinically stable for at least six months and are receiving usual treatment. The planned cohort includes 15 participants. Sleep patterns will be recorded at home using a sensor-equipped mattress topper for six months. Clinical assessments will include schizophrenia symptoms and everyday functioning, with additional assessments triggered by predefined changes in sleep.
Adults with a diagnosis of bipolar disorder who have been clinically stable for at least six months and are receiving usual treatment. The planned cohort includes 15 participants. Sleep patterns will be recorded at home using a sensor-equipped mattress topper for six months. Clinical assessments will include manic and depressive symptoms and everyday functioning, with additional assessments triggered by predefined changes in sleep.
Association Between Changes in Sleep duration and Early Relapse Symptoms
Association between changes in objectively recorded sleep duration and psychiatric symptom scores during follow-up. Sleep duration will be recorded using a sensor-equipped mattress topper. Symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS) in adults with a diagnosis of schizophrenia, and the Young Mania Rating Scale (YMRS) and Hamilton Depression Rating Scale (HDRS) in adults with a diagnosis of bipolar disorder.
Time frame: From baseline through 6 months, with monthly and sleep-alert-triggered symptom assessments.
Plan to share: No
Start is estimated for Feb 2027; primary completion for Aug 2027, 6 months later.
Of 95 non-industry observational studies under Bipolar Disorder, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 119. This study's planned 6 months is below that.
Counting every sponsor, half of 105 studies reached it within 64 months; a quarter within 31 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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International University of La Rioja