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Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of tones | Active Comparator | During non-rapid eye movement (NREM) sleep short tones will be played |
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| No application of tones | Sham Comparator | During NREM sleep no short tones will be played |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of tones | Device | During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham. | From baseline period to study completion, assessed up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Daily functioning - Mood | Mood will be digitally assessed using a daily mood scale over the intervention period | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks |
| Daily functioning - Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Device usability | Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition | From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Federal Institute of Technology | Zurich | Canton of Zurich | 8092 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35603302 | Derived | Lustenberger C, Ferster ML, Huwiler S, Brogli L, Werth E, Huber R, Karlen W. Auditory deep sleep stimulation in older adults at home: a randomized crossover trial. Commun Med (Lond). 2022 Apr 4;2:30. doi: 10.1038/s43856-022-00096-6. eCollection 2022. |
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| No application of tones | Device | This is the sham-control intervention; The device will only record biosignals but will not play tones. |
|
Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period |
| From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks |
| Daily functioning - Vigilance | Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks |
| Daily functioning - Cognition | Cognition will be assessed using a digital test battery before and after each intervention | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks |
| Physiological parameters - Cardiovascular | R-R interval based assessments will be obtained using wearable monitors | From baseline period to study completion, assessed up to 2 months |
| Physiological parameters - Physical activity | Physical activity levels will be obtained using wearable monitors | Through study completion, approximately 2 months |
| Diary |
Information about daily habits will be digitally assessed |
| Through study completion, approximately 2 months |
| Incidence of Intervention-related Adverse Events [Safety and Tolerability] | Any adverse or serious adverse events during the study period will be assessed | Through study completion, approximately 2 months |
| Chronotype | Assessment of circadian type | Before start of intervention period (single-time assessment during one initial 1-day visit) |
| Handedness | Assessment of handedness | Before start of intervention period (single-time assessment during one initial 1-day visit) |
| Menstrual cycle | Assessment of menstrual cycle information in woman | Before start of intervention period (single-time assessment during one initial 1-day visit) |
| Height | Assessment of height | Before start of intervention period (single-time assessment during one initial 1-day visit) |
| Hip-to-waist ratio | Assessment of hip and waist circumference | Before start of intervention period (single-time assessment during one initial 1-day visit) |
| Blood pressure | Assessment of blood pressure | Through study completion, approximately 2 months |
| Weight | Assessment of weight | Before start of intervention period (single-time assessment during one initial 1-day visit) |