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Not yet recruitingNCT07921667DESCANTUpdated Nov 6, 2026

Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment

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

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • 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
03

In context

Bipolar Disorder

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 site
08

References and documents

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 18519522 ↗
  • Gleeson 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 38065010 ↗
  • da 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 26630406 ↗
  • Schigel'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 1221601 ↗
  • Benson 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 17118280 ↗
  • Belvederi 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 29939361 ↗
  • Basquin 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Feb 2027
Primary completionEst.
Aug 2027
CompletionEst.
Jul 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07921667
Lead sponsor
International University of La Rioja
Collaborators
Hospital San Pedro de Logroño, Welltech Sleep Electronics, S.L.
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Feb 2027 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Sara Barbeito Resa, PhD
Contact
sara.barbeito@unir.net
+34 941 20 97 43
Javier Cortés, PhD
Contact
javier.cortes@unir.net
+34 941 20 97 43

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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