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Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

2026年8月31日 更新者: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).

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

観察的

入学 (推定)

100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • California
      • Los Angeles、California、アメリカ、90095
        • UCLA Center for Advanced Surgical & Interventional Technology (CASIT)
        • 主任研究者:
          • Bijan Najafi, PhD
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
モントリオール認知評価 (MoCA)
時間枠:12ヶ月
これは簡易的な全般的認知機能スクリーニング評価です。 スコアは0から30の範囲で、0はより悪い結果を表します。
12ヶ月
Dual Task physical activities changes from Baseline to 12 months
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Gait performance
時間枠: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
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月15日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2030年3月30日

試験登録日

最初に提出

2026年8月19日

QC基準を満たした最初の提出物

2026年8月19日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月2日

QC基準を満たした最後の更新が送信されました

2026年8月31日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • PAMSys Voice Phase II

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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