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治験 NCT04855630 (CASE)（対象：アルツハイマー病、認知症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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マイアミ大学Combating Alzheimer's Through Sleep and Exercise (CASE)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04855630 (CASE) は 介入研究 臨床試験 で、アルツハイマー病、認知症 に関するものです。現在は 募集中 で、2023年3月1日 から開始しています。30 名の参加者 の募集が計画されています。この治験は マイアミ大学 によって主催され、2026年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月24日 です。
概要
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
公式タイトル
Combating Alzheimer's Through Sleep and Exercise (CASE)
疾患／病気
アルツハイマー病認知症その他の研究識別子
- CASE
- 20220931
- 20-01023 (その他の識別子) (NYU)
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Sleep Only Group Participants in this group will wear the DREEM 2 headband for 12 weeks. | DREEM 2 Headband Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors). |
実薬対照薬Exercise Only Group Participants in this group will workout twice a week for 12 weeks. | Exercise Routine Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months. |
実薬対照薬Exercise and Sleep Group Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks. | DREEM 2 Headband Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors). Exercise Routine Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Total Cholesterol Levels | Measured from blood sample | Up to Week 12 |
High-Density Lipoprotein (HDL) Levels | Measured from blood sample | Up to Week 12 |
Low-Density Lipoprotein (LDL) Levels | Measured from blood sample | Up to Week 12 |
Triglycerides Levels | Measured from blood sample | Up to Week 12 |
High-sensitivity C-reactive protein (hs-CRP) Levels | Measured from blood sample | Up to Week 12 |
HbA1c Levels | Measured from blood sample | Up to Week 12 |
Heart Rate | Measured from Fitbit | Up to Week 12 |
Blood Pressure | Measured from Fitbit | Up to Week 12 |
Total Sleep Duration | Measured from DREEM 2 | Up to Week 12 |
Slow Wave Sleep Duration | Measured from DREEM 2 | Up to Week 12 |
Cortisol Levels | Measured from Urine Sample | Up to Week 12 |
Cortisone Levels | Measured from Urine Sample | Up to Week 12 |
Melatonin Levels | Measured from Urine Sample | Up to Week 12 |
Creatinine Levels | Measured from Urine Sample | Up to Week 12 |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
45 Years
対象性別
全て
- Able to perform mild exercise
- Able to wear DREEM 2 Headband
- Able to wear a Fitbit wrist watch
- Able to perform the Everlywell biomarker procedure
- Able to Understand and Speak English
- Able to operate a digital device like mobile phone, iPad, or computer
- Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
- Only participants cognitively able and willing to provide consent will be included.
- Prohibited from or unable to perform mild exercise
- Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
- Unable to speak or understand English
- Unable to use mobile device/smartphone technology
- Unable or unwilling to consent for any reason.
マイアミ大学290 件のアクティブな治験を探索- Shipley Foundation
- Dreem
責任者
Azizi Seixas, 研究責任者, Associate Professor, University of Miami
試験中央連絡先
連絡先: Azizi A Seixas, PhD, 3052431301, [email protected]
連絡先: Debbie Chung, PhD, 3052431301, [email protected]
1 1カ国の場所
Florida
University of Miami Hospitals, Miami, Florida, 33136, United States
Debbie Chung, PhD, 連絡先, 3052431301, [email protected]
Azizi A Seixas, PhD, 連絡先, 3052431301, [email protected]
Azizi A Seixas, PhD, 研究責任者
Debbie Chung, PhD, 副研究者
Alberto Ramos, MD, 副研究者
募集中