Effect of Vestibular Stimulation on Sleep in Elderly
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Zurich、スイス、8092
- Sensory Motor Systems Lab
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Right handed
- Between 60 and 75 years of age
Exclusion Criteria:
- Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
- BMI < 19 or > 30 kg/m2
- Medication known to influence sleep [56]
- Cognitive Impairment (MoCA score < 26)
- Drug use and abuse
- Nicotine use (e.g. smoking)
- > 10 alcoholic drinks per week
- > 5 drinks or foods containing caffeine per day
- History of sleep disorder (Insomnia, sleep apnea (apnea-hypopnea index >5), nocturnal myoclonus (>5 periodic leg movements per hour of sleep))
- Irregular sleep-wake rhythm (e.g. shift working)
- Travelling across time zones less than 1 month ago
- Naps longer than 1h
- Sleep on an average night <6 hours or >8 hours
- Skin allergies or very sensitive skin
- Diseases of the vestibular system
- Signs of motion sickness based on questionnaire
研究計画
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:基礎科学
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:Baseline Nights
No vestibular stimulation is applied.
However, the sound of the moving bed will be played back to the participant at the right sound intensity level.
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実験的:Movement Nights
Vestibular stimulation, in the form of gentle rocking movements, is provided using the Somnomat V4 rocking bed.
Stimulation is provided for the entire 7 hours of the night from lights off to lights on.
The stimulation frequency is in the range of 0.1-0.3
Hz, with an amplitude in the range of 0.05 to 0.1m
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Vestibular stimulation is provided using an innervated bed platform.
This robotic device consists of a standard single bed, mounted on a moving mechanism.
It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.
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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 |
---|---|---|
Polysomnography
時間枠:4 nights of 7 hours each
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Difference in sleep parameters between the second of two nights with intervention and the second of two nights without intervention, as recorded using polysomnography. The sleep stages will be scored visually on a 20-s epoch basis according to standard criteria [53]. This will allow us to compare sleep architecture of the participants in the two conditions, as well as a possible consecutive nights effect in the two movement nights. Parameters of specific interest are sleep onset latency, total sleep time, time spent in N1, N2 and N3 stages of NREM sleep and time spent in REM sleep. Furthermore, the EEG power density spectra will be analysed. Power in specific frequency bands will be calculated based on spectral analysis, the amount and density of sleep spindles and slow waves will be determined. |
4 nights of 7 hours each
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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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Memory performance
時間枠:Recall moment in evening and morning (4 nights)
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Difference in declarative memory performance between the second of two nights with intervention and the second of two nights without intervention.
During each experimental night a word-pair recall task will be performed 1h before going to bed and half an hour after waking up.
To assess declarative memory performance improvement, we will determine the difference between immediate and delayed recall.
Word-pair recall tasks are suitable to determine declarative memory performance in the context of sleep, as they are sensitive to effects of sleep.
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Recall moment in evening and morning (4 nights)
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Skin temperature
時間枠:4 nights of 7 hours each
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The distal-proximal temperature gradient will be calculated, based on skin temperature measured using sensors placed on the chest and hands, to look for a relationship with sleep onset latency.
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4 nights of 7 hours each
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協力者と研究者
捜査官
- 主任研究者:Robert Riener, Prof.、University of Zurich
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SOMNOMAT V4
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?
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Somnomat V4の臨床試験
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Kaneka CorporationClinSearchわからない
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Andrei IagaruNational Cancer Institute (NCI); National Institutes of Health (NIH)完了