Improvement of Depression Symptoms with Mobile Devices during Sleep
Descrizione riassuntiva dello studio
We still know little about the therapeutic potential of acoustic sleep modulation in a home setting as a non-medication treatment option for depressed patients. Therefore, we want to learn more about the effects of acoustic sleep modulation on symptoms and biomarkers in depressed patients and healthy controls. To this end, a mobile device is used, the so-called Tosoo sleep band. Study participants are randomly assigned to one of two groups. The first group begins with acoustic sleep modulation and receives a sham sleep modulation in the second intervention week. In the second group, the order of acoustic and sham sleep modulation is reversed. This means that both groups receive both acoustic and sham sleep modulation. Neither participants nor staff with direct contact with subjects know during which intervention week the acoustic sleep modulation takes place. The study lasts five weeks for participants, with four on-site visits and two online consultations. Three visits include an overnight stay in the sleep lab and during two of these visits, imaging using magnetic resonance imaging (MRI) is also performed. Throughout the study duration, daily activities are recorded. Two smartphone apps are used as well as an EKG patch that continuously measures heart activity, respiratory rate, and movement.
(BASEC)
Intervento studiato
The acoustic sleep modulation takes place at home using the mobile Tosoo sleep band. The device measures brain waves, eye movements, and muscle activity at the chin and detects when someone is in deep sleep. It then plays short, quiet tones that do not lead to awakening.
(BASEC)
Malattie studiate
Depression
(BASEC)
• Male and female adults aged 18-65 years • ≥17 points on the HDRS (patients, corresponding to at least moderate depression) or <8 points on the HDRS (healthy controls) • Stable or no medication antidepressant therapy, not acutely suicidal (patients) or no depressive episode in the history (healthy controls) (BASEC)
Criteri di esclusione
• Bipolar disorder or psychotic symptoms in the history • Relevant diseases or medications that pose a risk to the participant or that could affect the study results • Low stimulation efficiency (<500 stimulations recorded by the device, even after parameter optimization) during the screening night or in the 3 subsequent recordings at home, e.g., due to very little deep sleep (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Dr. Giulia Da Poian, Sensory-Moror Systems Lab, ETH Zurich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Giulia Da Poian
+41 78 943 7703
giulia.dapoian@clutterhest.ethz.chETH Zurich
(BASEC)
Informazioni generali
Sensory-Motor Systems Lab, IRIS, ETH Zurich
(ICTRP)
Informazioni scientifiche
Sensory-Motor Systems Lab, IRIS, ETH Zurich
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
20.12.2022
(BASEC)
ID di studio ICTRP
NCT05685771 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Assessing the symptomatic benefit of slow-wave activity reduction using wearables and sensor-based characterization of depression: a randomized, counter-balanced crossover study (BASEC)
Titolo accademico
Assessing the Symptomatic Benefit of Slow-wave Activity Reduction Using Wearables and Sensor-based Characterization of Depression: a Randomized, Counter-balanced Crossover Study (ICTRP)
Titolo pubblico
Sleep Modulation as Antidepressant Randomized Trial (ICTRP)
Malattie studiate
Depression;Healthy (ICTRP)
Intervento studiato
Device: Phase-targeted auditory stimulation (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 55 Years
Minimum age: 18 Years
Inclusion Criteria:
- Male and female adults aged 18-55 years
- Motivated, no aversion against technology
- Able to give informed consent as documented by signature, and to follow the
technical instructions
- Able to understand and speak German or English as required for the interview (HDRS)
and to answer the questionnaires
- Diagnosis of depression according to DSM-5 criteria (depressed) OR no diagnosis of
depression AND no depressive episode in the history (healthy)
- =17 points in Hamilton Depression Rating Score (HDRS, corresponding to at least
moderate-mild depression, depressed) OR <8 points in HDRS (healthy)
- Stable or no pharmacological antidepressant therapy, no acute suicidal tendency
(depressed)
Exclusion Criteria:
- Pregnant or lactating women, women planning to get pregnant during the study period
- Bipolar disorder or psychotic symptoms in the history
- Relevant disease or medication that could present a risk for the participant or that
could influence study findings
- Known sleep apnea (diagnosed or ESS =10 points) or periodic limb movement syndrome
- Known alcoholism or drug abuse
- Diagnosed hearing impairment/presbycusis
- Irregular intake of centrally depressing or stimulating medication known to alter
sleep EEG (e.g., benzodiazepines)
- History of traumatic brain injury (except for concussion) or neurosurgical
procedures/operations
- Known epilepsy or for any reason, intracranial space-occupying lesions or
(infectious or autoimmune) inflammatory diseases of the central nervous system
- Shift workers
- Inability to follow the procedures of the study, e.g., due to language problems,
dementia, etc.
- Skin diseases/skin problems (in the face/ear/chest area) or allergies that could be
aggravated by electrode application
- Conditions that may interfere with the MRI (e.g., MR unsafe cardiac pacemaker or a
defibrillator, MR unsafe metal in or near the head, spinal cord, eyes, or in the
chest)
- Indications of sleep apnea (Apnea Hypopnea Index >15/h) or periodic limb movement
syndrome (PLMS index >15/h) in the screening night
- Low stimulation efficiency (<500 stimulations detected by the device) in the
screening night or in 3 subsequent home recording nights, e.g., due to very little
deep sleep
- Participation in another clinical trial during the study period (ICTRP)
non disponibile
Endpoint primari e secondari
Depression severity (ICTRP)
Response rate;Subjective momentary sleepiness;Electroencephalographic (EEG) topography;MR Spectroscopy;Brain connectivity (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
ETH Zurich;University of Zurich;Psychiatric University Hospital, Zurich (ICTRP)
Contatti aggiuntivi
Giulia Da Poian, PhD, Sensory-Motor Systems Lab, IRIS, ETH Zurich (ICTRP)
ID secondari
2022-D0092 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05685771 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile