Bipolar Disorder (BD)DESCANTNCT07921667
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
An observational study of Bipolar Disorder (BD) and SCHIZOPHRENIA 1 (Disorder), run by International University of La Rioja at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2027to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Age outside the specified range.
- Language difficulties, intellectual disability, neurodevelopmental disorders, any form of dementia, or severe traumatic brain injury.
- No internet access at home.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
- Keywords
- Sleep Monitoring, Sleep Disturbances, Early Relapse Detection, Relapse Prodromes, Home-Based Monitoring, Non-Invasive Sleep Sensors, Schizophrenia, Bipolar Disorder
- Medical subject headings
- Bipolar Disorder, Parasomnias, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | 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. | |
| Bipolar Disorder | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline through 6 months, with monthly and sleep-alert-triggered symptom assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International University of La Rioja
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Pedro de Logroño, Welltech Sleep Electronics, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921667
- Sponsor's protocol ID
- PI: 127/2024
- Other IDs
- 2025_I_IDI_1/89627
- Acronym
- DESCANT
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harvey AG. Sleep and circadian rhythms in bipolar disorder: seeking synchrony, harmony, and regulation. Am J Psychiatry. 2008 Jul;165(7):820-9. doi: 10.1176/appi.ajp.2008.08010098. Epub 2008 Jun 2.
PubMed 18519522Gleeson JF, McGuckian TB, Fernandez DK, Fraser MI, Pepe A, Taskis R, Alvarez-Jimenez M, Farhall JF, Gumley A. Systematic review of early warning signs of relapse and behavioural antecedents of symptom worsening in people living with schizophrenia spectrum disorders. Clin Psychol Rev. 2024 Feb;107:102357. doi: 10.1016/j.cpr.2023.102357. Epub 2023 Nov 22.
PubMed 38065010da Silva Rde A, Mograbi DC, Camelo EV, Bifano J, Wainstok M, Silveira LA, Cheniaux E. Insight in bipolar disorder: a comparison between mania, depression and euthymia using the Insight Scale for Affective Disorders. Trends Psychiatry Psychother. 2015 Jul-Sep;37(3):152-6. doi: 10.1590/2237-6089-2015-0014.
PubMed 26630406Schigel'skii VI. [Thrombophilia index in marked coronary arteriosclerosis under conditions of functional test and complex treatment]. Vrach Delo. 1975 Aug;(8):34-7. No abstract available. Russian.
PubMed 1221601Benson KL. Sleep in schizophrenia: impairments, correlates, and treatment. Psychiatr Clin North Am. 2006 Dec;29(4):1033-45; abstract ix-x. doi: 10.1016/j.psc.2006.08.002.
PubMed 17118280Belvederi Murri M, Amore M. The Multiple Dimensions of Insight in Schizophrenia-Spectrum Disorders. Schizophr Bull. 2019 Mar 7;45(2):277-283. doi: 10.1093/schbul/sby092.
PubMed 29939361Basquin L, Maruani J, Leseur J, Mauries S, Bazin B, Pineau G, Henry C, Lejoyeux M, Geoffroy PA. Study of the different sleep disturbances during the prodromal phase of depression and mania in bipolar disorders. Bipolar Disord. 2024 Aug;26(5):454-467. doi: 10.1111/bdi.13429. Epub 2024 Apr 23.
PubMed 38653574
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07921667
- Acronym / sponsor ID
- DESCANT / PI: 127/2024
- Conditions
- Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
- Keywords
- Sleep Monitoring, Sleep Disturbances, Early Relapse Detection, Relapse Prodromes, Home-Based Monitoring, Non-Invasive Sleep Sensors, Schizophrenia, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- International University of La RiojaUniversity, hospital or other
- Collaborators
- Hospital San Pedro de Logroño, Welltech Sleep Electronics, S.L.
- Study start
- Feb 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | –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. |
| Bipolar Disorder | – | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Age outside the specified range.
- Language difficulties, intellectual disability, neurodevelopmental disorders, any form of dementia, or severe traumatic brain injury.
- No internet access at home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Changes in Sleep duration and Early Relapse Symptoms
Time frame: From baseline through 6 months, with monthly and sleep-alert-triggered symptom assessments.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 18519522Harvey AG. Sleep and circadian rhythms in bipolar disorder: seeking synchrony, harmony, and regulation. Am J Psychiatry. 2008 Jul;165(7):820-9. doi: 10.1176/appi.ajp.2008.08010098. Epub 2008 Jun 2.
- Background: PubMed 38065010Gleeson JF, McGuckian TB, Fernandez DK, Fraser MI, Pepe A, Taskis R, Alvarez-Jimenez M, Farhall JF, Gumley A. Systematic review of early warning signs of relapse and behavioural antecedents of symptom worsening in people living with schizophrenia spectrum disorders. Clin Psychol Rev. 2024 Feb;107:102357. doi: 10.1016/j.cpr.2023.102357. Epub 2023 Nov 22.
- Background: PubMed 26630406da Silva Rde A, Mograbi DC, Camelo EV, Bifano J, Wainstok M, Silveira LA, Cheniaux E. Insight in bipolar disorder: a comparison between mania, depression and euthymia using the Insight Scale for Affective Disorders. Trends Psychiatry Psychother. 2015 Jul-Sep;37(3):152-6. doi: 10.1590/2237-6089-2015-0014.
- Background: PubMed 1221601Schigel'skii VI. [Thrombophilia index in marked coronary arteriosclerosis under conditions of functional test and complex treatment]. Vrach Delo. 1975 Aug;(8):34-7. No abstract available. Russian.
- Background: PubMed 17118280Benson KL. Sleep in schizophrenia: impairments, correlates, and treatment. Psychiatr Clin North Am. 2006 Dec;29(4):1033-45; abstract ix-x. doi: 10.1016/j.psc.2006.08.002.
- Background: PubMed 29939361Belvederi Murri M, Amore M. The Multiple Dimensions of Insight in Schizophrenia-Spectrum Disorders. Schizophr Bull. 2019 Mar 7;45(2):277-283. doi: 10.1093/schbul/sby092.
- Background: PubMed 38653574Basquin L, Maruani J, Leseur J, Mauries S, Bazin B, Pineau G, Henry C, Lejoyeux M, Geoffroy PA. Study of the different sleep disturbances during the prodromal phase of depression and mania in bipolar disorders. Bipolar Disord. 2024 Aug;26(5):454-467. doi: 10.1111/bdi.13429. Epub 2024 Apr 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder (BD) and SCHIZOPHRENIA 1 (Disorder), run by International University of La Rioja at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Barbeito Resa, PhD (+34 941 20 97 43, sara.barbeito@unir.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Changes in Sleep duration and Early Relapse Symptoms (time frame: From baseline through 6 months, with monthly and sleep-alert-triggered symptom assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921667, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.