Intranasal Dexmedetomidine-esketamine on Sleep and Cognition in Older Adults With Mild-to-moderate Cognitive Impairment
2026年5月28日 更新者：Dong-Xin Wang、Peking University First Hospital
Impact of Intranasal Dexmedetomidine-esketamine on Sleep Quality and Cognitive Function in Older Adults With Mild-to-moderate Cognitive Impairment: a Randomized, Double-blind, and Placebo-controlled Trial
Patients with cognitive decline are frequently comorbid with sleep disorders which may in turn aggravate cognitive decline.
Sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension; low dose dexmedetomidine produce less side effects, but the sleep promoting effects are relatively weak.
Low dose esketamine also has sleep-promoting effects but may produce neuropsychiatric side effects.
Both dexmedetomidine and esketamine are approved for intranasal administration.
We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.
調査の概要
状態
まだ募集していません
詳細な説明
Along with aging population, the number of older adults with cognitive decline (such as Alzheimer's disease) is also increasing and constitutes a great challenge to public health. Normal sleep is important for maintaining both physical and mental health. However, patients with cognitive decline are frequently comorbid with sleep disorders which are associated with increased need of health care; sleep disorders may in turn aggravate cognitive decline in these patients.
Dexmedetomidine is a highly selective alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effects. In previous studies, infusion of sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension. Infusion of low dose dexmedetomidine is also effective in improving sleep quality with less side effects; however, the sleep promoting effects are relatively weak. Intranasal dexmedetomidine provides a non-invasive intervention and is used for sleep promotion in preoperative patients, but requires hemodynaamic monitoring due to potential side effects.
Ketamine is a noncompetitive N-Methyl-D-aspartic acid (NMDA) receptor antagonist and has been used as a dissociative anesthetic for decades. Esketamine is the S-enantiomer and has approximately twice the potency of ketamine. Recent studies showed that low dose esketamine also has anti-depressive and sleep-promoting effects. Intranasal esketamine has been approved for treatment-resistant depression, and is also used as premedication in children and to relieve postoperative pain in adults.
Even low dose ketamine/esketamine may produce neuropsychiatric side effects, which can be relieved by dexmedetomidine. A study in pediatric patients reported that intranasal co-administration of dexmedetomidine and esketamine produced synergetic effects on sedation. A study in adults showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled opioid analgesia improved both analgesia and sleep quality without increasing side effects. A recent trial in older adults indicated that intranasal dexmedetomidine-esketamine improved neurocognitive recovery after surgery.
We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.
研究の種類
介入
入学 (推定)
60
段階
- フェーズ 4
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
- 名前：Dong-Xin Wang, MD, PhD
- 電話番号：010-83572784
- メール：wangdongxin@hotmail.com
研究連絡先のバックアップ
- 名前：Jia-Hui Ma, PhD
- 電話番号：010-83575085
- メール：mjh@bjmu.edu.cn
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
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コンタクト：
- Dong-Xin Wang, MD, PhD
- 電話番号：010-83572784
- メール：wangdongxin@hotmail.com
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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
いいえ
説明
Inclusion Criteria:
- Aged ≥ 60 years.
- Meeting the clinical diagnostic criteria for Alzheimer's disease, with mild cognitive impairment (MoCA score 18-25) or moderate cognitive impairment (MoCA score 10-17) due to Alzheimer's disease.
- Comorbid with sleep disorders (Pittsburgh Sleep Quality Index [PSQI] score ≥ 7).
- Signed informed consent.
Exclusion Criteria:
- Cognitive impairment/dementia due to other causes (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease dementia).
- Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause).
- Inability to communicate due to visual, auditory, language, or other reasons, or Mini-Mental State Examination (MMSE) score ≤ 9 or MoCA score ≤ 9.
- History of schizophrenia, epilepsy, or Parkinson's disease, or confirmed diagnosis of glaucoma, hyperthyroidism, pheochromocytoma, or myasthenia gravis.
- Confirmed diagnosis of restless legs syndrome or sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea according to STOP-Bang score, or Body Mass Index (BMI) > 30 kg/m2.
- History of stroke or transient ischemic attack within 12 months prior to enrollment, confirmed intracranial aneurysm, or elevated intracranial pressure from any cause.
- Uncontrolled hypertension (e.g., hypertensive crisis or systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg prior to enrollment), myocardial infarction, unstable angina, revascularization surgery within 12 months prior to enrollment, or NYHA class III.
- Sick sinus syndrome, severe sinus bradycardia (heart rate < 50 beats/min), atrioventricular block above degree II without a pacemaker, corrected QT interval (Fridericia-corrected QTcF) ≥ 450 ms, or other severe arrhythmias (e.g., frequent premature ventricular contractions).
- Uncontrolled diabetes (e.g., HbA1c > 9%, diabetic ketosis, hyperglycemic coma, or hypoglycemia).
- Severe hepatic dysfunction (Child-Pugh Class C), renal dysfunction (eGFR ≤ 30 ml/min/1.73m2), respiratory insufficiency (SpO2 < 93% on room air), or other severe diseases (e.g., frailty with inability to walk independently, advanced-stage tumors).
- Alcohol or drug dependence (manifested as strong cravings, uncontrolled use, and withdrawal symptoms upon cessation), or use of contraindicated medications.
- Major surgery under general anesthesia within 12 weeks prior to enrollment, or planned surgery within 12 weeks.
- Allergy to dexmedetomidine and/or esketamine.
- Participation in other interventional clinical studies.
- Any other conditions deemed unsuitable for study inclusion by the investigator.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Intervention group
Participants in this arm will receive intranasal administration of dexmedetomidine-esketamine combination. The dosage will be calculated based on body weight (approximately 0.4 μg/kg of dexmedetomidine and 0.2 mg/kg of esketamine). The mixture of study drugs will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached. The combination will be administered twice a week for 4 consecutive weeks (8 sessions in total). |
The dosage will be calculated based on body weight (approximately 0.4 μg/kg of dexmedetomidine and 0.2 mg/kg of esketamine).
The mixture of study drugs will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached.
The combination will be administered twice a week for 4 consecutive weeks (8 sessions in total).
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プラセボコンパレーター：Placebo group
Participants in this arm will receive intranasal administration of placebo (normal sline). The dosage (volume) will be calculated based on body weight in the same way as that in the intervention group. The placebo (normal saline) will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached. The placebo will be administered twice a week for 4 consecutive weeks (8 sessions in total). |
The dosage (volume) will be calculated based on body weight in the same way as that in the intervention group.
The placebo (normal saline) will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached.
The placebo will be administered twice a week for 4 consecutive weeks (8 sessions in total).
他の名前：
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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 |
|---|---|---|
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Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 1 month
時間枠：Up to day 29 post-intervention initiation
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Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) .
This is a self-report questionnaire including 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component is scored from 0 to 3; the global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
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Up to day 29 post-intervention initiation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Montreal Cognitive Assessment (MoCA) score from baseline to 1, 2, and 3 months
時間枠：Up to days 29, 57, and 85 post-intervention initiation
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Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better function).
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Up to days 29, 57, and 85 post-intervention initiation
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Changes in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 2 and 3 months
時間枠：Up to days 57 and 85 post-intervention initiation
|
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) .
This is a self-report questionnaire including 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each component is scored from 0 to 3; the global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
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Up to days 57 and 85 post-intervention initiation
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Objective sleep parameters assessed by actigraphy
時間枠：During the night after each intervention (days 1, 4, 8, 11, 15, 18, 22, and 25)
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Objective sleep parameters, including Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), and Wake After Sleep Onset (WASO), will be monitored continuously using a wearable wrist actigraphy device.
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During the night after each intervention (days 1, 4, 8, 11, 15, 18, 22, and 25)
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Subjective sleep quality assessed by Numeric Rating Scale (NRS)
時間枠：The morning following each intervention (days 2, 5, 9, 12, 16, 19, 23, and 26)
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Subjective sleep quality will be evaluated using an 11-point Numeric Rating Scale (NRS).
The score ranges from 0 to 10, where 0 represents the "best sleep" and 10 represents the "worst sleep".
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The morning following each intervention (days 2, 5, 9, 12, 16, 19, 23, and 26)
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Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to 1, 2, and 3 months
時間枠：Up to days 29, 57, and 85 post-intervention initiation
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Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 includes 9-item requiring responses of 0 (not at all) to 3 (nearly every day) to assess the occurrence of depressive symptoms over the last two weeks.
It has 8 items on depressive symptoms and 1 focused on suicidal ideation.
Total scores range from 0 to 27, with higher score indicating more severe symptoms.
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Up to days 29, 57, and 85 post-intervention initiation
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Change in Activities of Daily Living (ADL) score from baseline to 1, 2, an 3 months
時間枠：Up to days 29, 57, and 85 post-intervention initiation
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The Activities of Daily Living (ADL) scale evaluates basic activities of daily living (BADL) and instrumental activities of daily living (IADL).
The total score ranges from 14 to 56, with higher scores indicating more severe impairment of daily living ability.
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Up to days 29, 57, and 85 post-intervention initiation
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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。
捜査官
- 主任研究者：Dong-Xin Wang, MD, PhD、Peking University First Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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6月1日
一次修了 (推定)
2027年11月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-0208
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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