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Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

31 agosto 2026 aggiornato da: BioSensics

A Multi-Modal Wearable Sensor for Early Detection of Cognitive Decline and Remote Monitoring of Cognitive-Motor Decline Over Time

This observational study will enroll approximately 100 participants evenly split by cognitive status (Cognitively Impaired vs Non-Cognitively Impaired), and involves four clinic visits over one year (at baseline, 3, 6, and 12 months), each followed by 7 days of remote monitoring to assess the long-term feasibility of PAMSys+ (Physical Activity Monitoring System).

Panoramica dello studio

Descrizione dettagliata

Understanding someone's language abilities through analyzing their speech using digital tools can be a new, relevant way to find early signs of dementia. Past research shows that changes in a person's speech can accurately reflect the severity of dementia and could even predict cognitive decline before a clinical diagnosis of Alzheimer's disease (AD) is made. Clinical trials have shown that changes in speech can be more noticeable than using traditional screening methods, like the MMSE. Moreover, recent findings suggest that speech changes related to cognitive decline over time aren't influenced by practice or learning effects. Separately, our own research has found that observing people while they're doing two things at once, like walking and talking (known as dual-tasking), can help identify people with mild cognitive impairment, which is an early stage of AD. So, with the support of the studies mentioned above, the goal of this study is to better detect early signs of dementia using everyday behaviors, such as dual-task activities and speech patterns, like how long a person talks while walk at the same time. Investigators intend to create a cheap, simple-to-use pendant device that tracks these behaviors, allowing us to predict small changes in cognitive and motor functions over time.

This is an observational, minimally invasive study. There are four clinic visits (baseline, 3, 6, and 12 months) each followed by 7 days of monitoring. Research staff will supervise tests for all assessments to minimize the risk associated tests such as gait and balance assessments. All in-clinic visits will be conducted at UCLA Health sites.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • California
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA Center for Advanced Surgical & Interventional Technology (CASIT)
        • Investigatore principale:
          • Bijan Najafi, PhD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adults 55 years or older with mild cognitive impairement, and non-cognitively impaired.

Descrizione

Inclusion Criteria:

  • Adults age 55 years or older
  • Ambulatory (able to walk 40 feet with or without walking assistance)
  • Willing and able to provide informed consent.
  • Individuals in the cognitive impairment group, should either have a diagnosis of cognitive impairment, a MoCA score of 25 or lower, or be confirmation of cognitive impairment by the Principal Investigator or clinical collaborators based on self-reported memory problems and relevant patient history. Individuals in the non-cognitively impaired group must have a MoCA score of 26 or higher.

Exclusion Criteria:

  • Children and younger adults: We exclude children and younger adults (younger than 55 years old) as dementia and cognitive-motor impairment is anticipated to be lower among those younger than 55.
  • Immobility or major mobility disorder: We will exclude those who were bedbound or unable to stand or ambulate with or without walking assistance (e.g., cane, walker) that prohibit them from performing the 40-foot walking test needed for the Fried Frailty Criteria.
  • Pre-existing acute conditions: We will exclude those with acute or unstable conditions (e.g., fractures) that may significantly affect gait and balance, according to the judgement of clinical investigators. In addition, we will exclude those with any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study.
  • Medication: Changes in medication regime unrelated to dementia or those taken temporarily that may affect balance and/or gait (e.g., narcotic, anxiety medication) based on judgement of our clinical investigators.
  • Severe vision, aphasia, or healing problems: We will exclude those with major hearing, aphasia, or visual problems, which may limit their ability to complete patient-reported outcomes, complete the cognitive screening assessments, and may impact Dual Task physical activities. Those with corrected vision or hearing problems (e.g., using prescription glasses, hearing aids, etc.) will be included.
  • Ongoing treatment: We will exclude those receiving active therapy (e.g., undergoing active chemotherapy or radiotherapy).
  • Lack of capacity to consent.
  • Other exclusion criteria include the inability to use telemedicine (e.g., no internet at home, severe visual or hearing problem, lack of caregiver support, etc.); inability or unwillingness to participate in scheduled in clinic visits (e.g., living farther than 30 miles from the clinic, unavailability of caregivers). We will also exclude those with significant cognitive impairment (MoCA score<16), severe dementia, severe apathy, severe aphasia or speaking problems, severe depression, those who are on hospice care or palliative care, those with severe pain, and with history of drug or alcohol abuse over the last six months. Finally, we will exclude those who are unable to communicate in English or are unlikely to fully comply with the follow-up protocol (e.g., long travel distance).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Cognitively Impaired
Adults with mild cognitive impairment diagnosis or a MoCA scoring of 25 or lower.
Non-Cognitively Impaired
Adults without mild cognitive impairment diagnosis and MoCA scoring of 26 or higher

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Montreal Cognitive Assessment (MoCA)
Lasso di tempo: 12 mesi
Questo è un breve test di screening cognitivo globale. I punteggi vanno da 0 a 30, dove 0 rappresenta un risultato peggiore.
12 mesi
Dual Task physical activities changes from Baseline to 12 months
Lasso di tempo: 12 months
Changes in Dual Task physical activities such as gait duration, frequency, cadence, and step variability. Likewise, speech phenotypes such as speech duration, rate, and pause during Dual Task as measured by PAMSys+
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gait performance
Lasso di tempo: 12 months
At each site visits participants will wear LEGSys wearable sensors to collect 15-meter walk at habitual speed, fast speed, and dual task walking (walking while counting backward) The stride velocity unit is m/s.
12 months
Mobility performance
Lasso di tempo: 12 months
Mobility performance will be collected for duration of one week at each study visit using PAMSys+ to collect: posture duration (e.g., sitting, lying, standing, and walking), daily walking performance (e.g., step count, walking bout count), and postural transition (e.g., total number of sit-to-stand transition, average duration of sit-to-stand postural transition)
12 months
Lawton Instrumental Activities of Daily Living (IADL)
Lasso di tempo: 12 months
The Lawton Instrumental Activities of Daily Living (IADL) Scale is an 8-item questionnaire that evaluates an individual's ability to live independently. The questionnaire is scored from 0 to 8, where 0 represents a worse outcome.
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 dicembre 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

30 marzo 2030

Date di iscrizione allo studio

Primo inviato

19 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2026

Primo Inserito (Effettivo)

21 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • PAMSys Voice Phase II

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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