SLE

Ackaert 2014

Study Aim
Treatment Dementia
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Pharmacological
Intervention
AZD5213 // Placebo
Dosage and Duration
4 weeks of treatment of three different doses of AZD5213
Health Status/Diagnosis
Alzheimer disease (AD) // Mild Cognitive Impairment (MCI)

Dichter 2021

Study Aim
Treatment Dementia
Current Status of Trial
Protocol/Planned
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Sleep management
Study ID(s) and Acronym(s)
MoNoPol-sleep
Dosage and Duration
This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two "sleep nurses" as change agents per nursing home, (3) a basic education course for nursing staff: "Sleep problems in dementia", (4) an advanced education course for nursing staff: "Tailored problem-solving" (two workshops), (5) workshops: "Development of an institutional sleep-promoting concept" (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and "One Minute Wonder" poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio.
Health Status/Diagnosis
Dementia

NCT03066518

Study Aim
Treatment Dementia
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Pharmacological
Intervention
Melatonin//Placebo

NCT03001557

Study Aim
Treatment Dementia
Current Status of Trial
Ongoing
Study Design
RCT
Intervention type
Pharmacological
Intervention
Lemborexant//Dosage of drug//Placebo
Study ID(s) and Acronym(s)
NCT03001557 / E2006-G000-202

Wan 2013

Study Aim
Cognitive Enhancement (healthy)
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Both
Intervention
Nap//Wake//Nap and Caffeine//Dosage of Caffeine//Placebo
Dosage and Duration
Each participant completed 4 experimental sessions, including Wake (W), Nap only (Nap0), Nap with 100mg caffeine (Nap100), and Nap with 200mg caffeine (Nap200), with intervals of one-week. Participants were required to stay awake in W condition, and were required to take a nap in a 1-h window in the remaining 3 conditions. Placebo or caffeine-containing solutions were administered before rest/nap.
Health Status/Diagnosis
Healthy Persons
Study log
<p>
Introduction: Previous studies demonstrated that daytime nap contributed to sleep-dependent memory consolidation, and some studies suggested that nap combined with the use of caffeine have additional benefit on cognitive functioning. However, such effect has not been examined in the elderly population. The present study aimed to examine the effect of nap, combined with the use of different dosages of caffeine, on memory processing in elderly. Materials and methods: The present study recruited twenty-four healthy elderly aged between 61 and 80 years (70.58 + 5.24 years), <span data-scayt_word="whowere" data-scaytid="4">whowere</span> habitual nappers and non- <span data-scayt_word="tomoderate" data-scaytid="5">tomoderate</span>- caffeine consumers. We adopted a randomized, double-blind, placebo-controlled <span data-scayt_word="withinsubject" data-scaytid="6">withinsubject</span> design. Each participant completed 4 experimental sessions, including Wake (W), Nap only (<span data-scayt_word="Nap0" data-scaytid="7">Nap0</span>), Nap with 100 mg caffeine (<span data-scayt_word="Nap100" data-scaytid="9">Nap100</span>), and Nap with 200 mg caffeine (<span data-scayt_word="Nap200" data-scaytid="11">Nap200</span>), with intervals of one-week. Participants were required to stay awake in W condition, and were required to take nap in a 1-h window in the remaining 3 conditions. Placebo or caffeine-containing solutions were administered before rest/nap. <span data-scayt_word="Electrophysiological" data-scaytid="13">Electrophysiological</span> <span data-scayt_word="activitiesweremonitored" data-scaytid="14">activitiesweremonitored</span> by <span data-scayt_word="polysomnography" data-scaytid="15">polysomnography</span> (<span data-scayt_word="PSG" data-scaytid="16">PSG</span>). A <span data-scayt_word="declarativememory" data-scaytid="17">declarativememory</span> task and a <span data-scayt_word="proceduralmemory" data-scaytid="19">proceduralmemory</span> task were administered before and after the rest/ nap. Results: Two-way repeated measures ANOVA revealed no main effect of condition on declarative or procedural memory. Correlation analysis on the relationship between sleep oscillation (spindle (<span data-scayt_word="Sp" data-scaytid="21">Sp</span>) density and slow wave activity (<span data-scayt_word="SWA" data-scaytid="26">SWA</span>) density) and post-nap changes in declarative and <span data-scayt_word="proceduralmemory" data-scaytid="20">proceduralmemory</span> showed that in <span data-scayt_word="Nap0" data-scaytid="8">Nap0</span> condition, <span data-scayt_word="Sp" data-scaytid="22">Sp</span> density was associated with improvement on procedural and declarative memory; and <span data-scayt_word="SWA" data-scaytid="27">SWA</span> density was associated with improvement on declarative memory. In <span data-scayt_word="Nap100" data-scaytid="10">Nap100</span> condition, <span data-scayt_word="Sp" data-scaytid="23">Sp</span> density showed association with improved declarative memory, and <span data-scayt_word="SWA" data-scaytid="28">SWA</span> density showed association with improvement on both procedural and <span data-scayt_word="declarativememory" data-scaytid="18">declarativememory</span>. In <span data-scayt_word="Nap200" data-scaytid="12">Nap200</span> condition, <span data-scayt_word="onlySWA" data-scaytid="30">onlySWA</span> density showed correlation with improvement on procedural and declarative memory. Conclusion: The benefit of nap on memory consolidation was not found in elderly based on the <span data-scayt_word="behavioural" data-scaytid="31">behavioural</span> measurement. Analysis on sleep oscillation showed that <span data-scayt_word="Sp" data-scaytid="24">Sp</span> density and <span data-scayt_word="SWA" data-scaytid="29">SWA</span> density were associated with post-nap improvement on declarative and procedural memory, which was similar to the pattern reported in young adults. Association between <span data-scayt_word="Sp" data-scaytid="25">Sp</span> and post-nap memory improvement was absent in conditions involved use of caffeine. The underlying mechanism remained to be addressed.</p>
<p>
Coded from the abstract</p>
Edit status
Assigned

Ablin 2013

Study Aim
Cognitive Enhancement (healthy)
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Exercise Cessation//Sleep Restriction//Both Exercise Cessation and Sleep Restriction//Neither Exercise Cessation or Sleep Restriction
Dosage and Duration
Exercise cessation or sleep restriction or both exercise cessation and sleep restriction or no exercise cessation or sleep restriction for 10 days
Health Status/Diagnosis
Healthy Persons
Study log
<p>
Coded from the abstract</p>
<p>
&nbsp;</p>
<p>
OBJECTIVES: Exposure to acute &#39;stressors&#39; (e.g. infections, pain, trauma) often results in altered sleep habits and reductions in routine activity. In some individuals, these <span class="scayt-misspell" data-scayt_word="behavioural" data-scaytid="19">behavioural</span> responses to acute stressors may contribute to the development of chronic somatic symptoms such as widespread pain, fatigue, memory difficulties and mood disturbances, much like those associated with &#39;functional somatic syndromes&#39; (<span class="scayt-misspell" data-scayt_word="FSS" data-scaytid="21">FSS</span>) such as fibromyalgia or chronic fatigue syndrome. // METHODS: Eighty-seven healthy young adults who reported sleeping between 7 and 9 hours nightly and exercising regularly were <span class="scayt-misspell" data-scayt_word="randomised" data-scaytid="23">randomised</span> to one of four groups: exercise cessation, sleep restriction (6 hours nightly), both, or neither. Symptoms of pain, fatigue, cognitive dysfunction and negative mood were measured before and after the 10-day restriction period. // RESULTS: Sleep restriction was a potent contributor to the development of somatic symptoms. Exercise cessation was less influential leading only to fatigue. There were no significant interactions between exercise cessation and sleep restriction, except that males were much more likely to develop somatic symptoms when deprived of both sleep and exercise than one or the other. Women were generally much more likely to develop somatic symptoms than men. // CONCLUSIONS: This study supports previous research suggesting that both sleep and exercise are critical in &#39;preventing&#39; somatic symptoms among some individuals. Furthermore, to our knowledge, this is the first time there is data to suggest that women are much more sensitive to decrements in routine sleep and exercise than are men.</p>
Edit status
Assigned

Sun 2013

Study Aim
Cognitive Enhancement (healthy)
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Self-relaxation Training (Progressive Muscle Relaxation and Meditation)//Sleep Hygiene Education
Dosage and Duration
During the first month, there were four sessions of group relaxation practice for the experimental group, 1 per week, 90 minutes per session. From the second month, participants were requested to practice PMR and meditation at home at least three times a day, 30 minutes each time, for one year. In the sleep education group, each participant received a brochure of routine sleep hygiene guidelines and were instructed to maintain good sleep habits.
Health Status/Diagnosis
Healthy Persons

Renn 2013

Study Aim
Primary Prevention
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Sleep Deprivation//No Sleep Deprivation
Dosage and Duration
Sleep deprived participants remained awake for approximately 34 hours while the control group had an 8 hour sleep opportunity.
Health Status/Diagnosis
Healthy Persons

Os 2012 / NTR3242

Study Aim
Treatment Dementia
Current Status of Trial
Ongoing
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Physio Acoustic Sound (PAS) Therapy//No Therapy
Study ID(s) and Acronym(s)
NTR3242
Dosage and Duration
After an initial baseline period of two weeks, the intervention group participants will sleep on a bed identical to their own, but with a mattress containing an in-built PAS device. As soon as the patient is lying in bed, the computer programme inducing the vibrations will be switched on for 30 min. The frequencies used in the programme lie between 27 and 40 Hz en will vary every two or three minutes. There will be a two week wash-out period after the two week intervention period. The control group participants will sleep in their own beds for the 6 weeks.
Health Status/Diagnosis
Dementia

Almeida Valverde Zanini 2012

Study Aim
Cognitive Enhancement (healthy)
Current Status of Trial
Completed
Study Design
RCT
Intervention type
Non-pharmacological
Intervention
Total Sleep Deprivation (TSD) Followed by Recovery Sleep//No Sleep Deprivation
Dosage and Duration
2 nights of TSD followed by 1 night of recovery sleep or no sleep deprivation
Health Status/Diagnosis
Healthy Persons
Edit status
Assigned