Temperature Optimization for Sleep (SIESTA Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByAmir Baniassadi
Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hebrew SeniorLife
No Placebo Group
Trial Summary
What is the purpose of this trial?Nearly 50% of older adults complain of poor habitual sleep, and in many cases the underlying reason remains undiagnosed or unknown. Meanwhile, observational data suggest that bedroom temperature significantly influences sleep quality in community-dwelling older adults, including those without financial constraints that limit the use of heating and cooling. These individuals often struggle to maintain an optimal bedroom temperature, either due to impaired motor function and cognitive abilities, and/or a lack of awareness about how temperature affects their sleep. Therefore, for a non-trivial portion of older adults, optimizing the bedroom temperature presents an exciting and untapped opportunity to improve sleep without substantial cost, burden, and side effects. The intervention, biologically adaptive control of bedroom temperature, uses wearable health trackers (e.g., a Garmin watch) and smart thermostats to automate and personalize bedroom temperature control, tailoring it to each person's unique physiology and context. Initially, individuals will be monitored in their home to determine each person's specific temperature range that promotes sleep quality, as measured by the wearable device. After the initial monitoring, the smart thermostat will maintain bedroom temperature within the optimal range for sleep for as long as the individual uses the intervention.
The primary purpose of this project is to test the feasibility of biologically adaptive control of bedroom temperature as an intervention to improve sleep in older adults and gather preliminary data to facilitate sample size calculations for a definitive trial. 20 Older adults, aged 65 and above, will be enrolled and their bedrooms bedrooms will be equipped with smart thermostats. The first aim focuses on assessing the feasibility of the intervention. This includes evaluating participant recruitment and retention, the acceptability of temperature adjustments (tracked through the number of temperature overrides by participants), and the self-reported likelihood of future use. The second aim involves analyzing the mean and variance of sleep outcomes during observation and intervention phases (separately for each group), examining the degree to which they vary with temperature variations and behavioral adaptations.
Will I have to stop taking my current medications?
The trial requires participants to have stable medication, which means you should not need to stop taking your current medications if they are stable. However, if your medications are not stable, you may not be eligible to participate.
How does the treatment Biologically Adaptive Control of Bedroom Temperature differ from other sleep treatments?
This treatment is unique because it focuses on optimizing bedroom temperature to improve sleep by using biologically adaptive control, which adjusts the environment based on the body's natural temperature changes. Unlike medications or other interventions, it leverages the body's thermoregulation to enhance sleep quality without altering core body temperature.
13579Is temperature optimization for sleep generally safe for humans?
Research suggests that manipulating skin temperature within a comfortable range is generally safe for humans, as studies have shown it can affect sleep onset and maintenance without significant adverse effects.
12578What data supports the effectiveness of the treatment Biologically Adaptive Control of Bedroom Temperature for optimizing sleep?
Research shows that controlling bedroom temperature can improve sleep quality by increasing slow-wave sleep (deep sleep) and REM sleep (a sleep stage important for memory and mood). Additionally, warming the skin can help people fall asleep faster, suggesting that temperature adjustments can positively influence sleep patterns.
14568Eligibility Criteria
This trial is for older adults aged 65 and above who experience poor sleep quality. Participants should be able to use a wearable health tracker and have a smart thermostat installed in their bedroom. There's no mention of specific exclusion criteria, but typically those with severe medical conditions or cognitive impairments that would interfere with the study may not qualify.Inclusion Criteria
I am 65 years old or older.
Exclusion Criteria
I need help from others to walk.
I have been diagnosed with dementia or a major neurological disease like Parkinson's, stroke, or MS.
I have been diagnosed with type 2 diabetes by a doctor.
I do not have any unstable mental health conditions.
I do not have any unstable health conditions like active cancer, uncontrolled high blood pressure, or recent heart issues.
Participant Groups
The study tests if controlling bedroom temperature using smart thermostats can improve sleep in older adults. It uses wearable trackers to find each person's ideal sleeping temperature, then adjusts their room accordingly to see if it helps them sleep better.
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
After the initial monitoring, the bedroom temperature for the experimental group will be set to what is deemed optimal for their sleep. Participants will always have the option of overriding our prescribed temperature.
Group II: ControlExperimental Treatment1 Intervention
After the initial monitoring, the control group will control their own bedroom temperature.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Hebrew SeniorLifeBoston, MA
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Who is running the clinical trial?
Hebrew SeniorLifeLead Sponsor
References
The effects of high and low ambient temperatures on human sleep stages. [2019]Six male subjects slept nude except for shorts on a bed made from nylon webbing at 5 different ambient temperatures (TaS): 21, 24, 29 (thermoneutrality), 34 and 37 degrees C. Standard electrophysiological recordings were obtained and analyzed for sleep stages. Temperature displayed a significant quadratic trends for nearly every sleep variable, such that TaS above or below thermoneutrality had similar effects on sleep patterns. Multiple comparisons showed that 21 degrees C was the most disruptive condition, and that cold TaS were generally more disruptive to sleep than warm TaS. There were marked individual differences in sensitivity of sleep to cold. Decreases in REM sleep in humans produced by heat or cold probably result from a general disruption of sleep processes rather than being specifically related to the status of the thermoregulatory system during REM sleep.
A system with some unique features for maintaining desired body temperature in anesthetized and/or immobilized animals. [2019]We describe the design and unique features of a system for precisely regulating body temperature of anesthetized and/or immobilized small mammals during prolonged neurophysiological experiments. The system uses a flexible, insulated, charcoal cloth conducting blanket which can be intimately wrapped around the animal's body. The temperature of the blanket is continuously regulated by an electronic system which compares the animal's actual temperature with the desired temperature. The system can react to differences of 0.1 to 0.001 degrees C and introduces no recording artifacts. With modification the system may have clinical application.
Selective increases in non-rapid eye movement sleep following whole body heating in rats. [2019]Afternoon body heating has been reported to increase amounts of slow wave sleep (SWS) during the subsequent night in humans. This delayed effect of body heating on SWS has not been previously studied in laboratory animals. We examined the effect of whole body heating during the last 4 h of the light period on sleep and brain temperature (Tbr) during the subsequent twelve hour period in rats. Whole body heating was accomplished by elevating ambient temperature, typically to 33-35 degrees C, which increased Tbr to 40 +/- 0.5 degrees C. This condition was compared to a sleep-matched control condition, a sleep-deprived control condition and to a baseline condition. Following heating, non-rapid eye movement sleep 2 (NREMS2 or deep NREMS) was significantly increased during the first 2 h of the recovery period compared with baseline and sleep-matched control conditions and during the first hour compared with the totally sleep-deprived condition. NREMS1 was not significantly changed by heating. Rapid eye movement sleep was not different following heating compared to the sleep-matched and sleep-deprived control conditions but was significantly increased during the first hour of the recovery period following heating compared to baseline. Tbr was significantly lower for the first 5 h and the 7th h following heating compared to all three other conditions. Possible relationships between the regulation of sleep and temperature are discussed.
Thermoregulation as a sleep signalling system. [2022]Temperature and sleep are interrelated processes. Under normal environmental conditions, the rhythms of core body temperature Tc and sleep propensity vary inversely across the day and night in healthy young adults. Although this relationship has drawn considerable interest, particularly in recent years, it is still not known whether this relationship is causative or merely coincidental. As somnogenic brain areas contain thermosensitive cells, it is possible that the sleep/wake cycle may be directly affected by thermoregulatory changes themselves. That is, that changes in temperature may trigger, either directly or indirectly, somnogenic brain areas to initiate sleep. There is now an emerging body of evidence from both physiological and neuroanatomical studies to indicate that this may indeed be the case. This paper will examine the literature relating to this relationship and propose a model where thermoregulatory changes provide an additional signal to the brain regions that regulate sleep and wakefulness. The model attempts to explain how temperature changes before and after sleep onset act in a positive feedback loop to maintain a consolidated sleep bout.
Cutaneous warming promotes sleep onset. [2022]Sleep occurs in close relation to changes in body temperature. Both the monophasic sleep period in humans and the polyphasic sleep periods in rodents tend to be initiated when core body temperature is declining. This decline is mainly due to an increase in skin blood flow and consequently skin warming and heat loss. We have proposed that these intrinsically occurring changes in core and skin temperatures could modulate neuronal activity in sleep-regulating brain areas (Van Someren EJW, Chronobiol Int 17: 313-54, 2000). We here provide results compatible with this hypothesis. We obtained 144 sleep-onset latencies while directly manipulating core and skin temperatures within the comfortable range in eight healthy subjects under controlled conditions. The induction of a proximal skin temperature difference of only 0.78 +/- 0.03 degrees C (mean +/- SE) around a mean of 35.13 +/- 0.11 degrees C changed sleep-onset latency by 26%, i.e., by 3.09 minutes [95% confidence interval (CI), 1.91 to 4.28] around a mean of 11.85 min (CI, 9.74 to 14.41), with faster sleep onsets when the proximal skin was warmed. The reduction in sleep-onset latency occurred despite a small but significant decrease in subjective comfort during proximal skin warming. The induction of changes in core temperature (delta = 0.20 +/- 0.02 degrees C) and distal skin temperature (delta = 0.74 +/- 0.05 degrees C) were ineffective. Previous studies have demonstrated correlations between skin temperature and sleep-onset latency. Also, sleep disruption by ambient temperatures that activate thermoregulatory defense mechanisms has been shown. The present study is the first to experimentally demonstrate a causal contribution to sleep-onset latency of skin temperature manipulations within the normal nocturnal fluctuation range. Circadian and sleep-appetitive behavior-induced variations in skin temperature might act as an input signal to sleep-regulating systems.
Basic Study for Optimal Control of In-Bed Temperature during Sleep. [2020]It is important to create a comfortable environment to restful sleep. In this study, we trial-produced an in-bed temperature control system. At first, we statically controlled the temperature in the subject's bed at 32°C by using the system, and examined how this control affected sleep. We were able to confirm that the ratio of slow-wave sleep (SWS) increased in comparison to cases in which the temperature in the bed was not controlled. Next, the temperature in the subject's bed was dynamically controlled at temperature change patterns according to sleep cycles that is as follows; Heating during the REM sleep period and cooling during the SWS sleep period were conducted n the range of 32±2°C, and the case of the opposite phase. The result showed that cooling during the REM period increased the REM sleep share rate. Based on these results, an increase of the REM sleep share rate at around 30°C could be confirmed, indicating a possibility that the REM period thermoneutrality zone shifted to a lower temperature, compared with that of SWS.
Skin deep: enhanced sleep depth by cutaneous temperature manipulation. [2019]With ageing, an increasingly disturbed sleep is reported as a significant complaint affecting the health and well-being of many people. The available treatments for sleep disturbance have their limitations, so we have adopted a different approach to the improvement of sleep. Since in animal and human studies skin warming has been found to increase neuronal activity in brain areas that are critically involved in sleep regulation, we investigated whether subtle skin temperature manipulations could improve human sleep. By employing a thermosuit to control skin temperature during nocturnal sleep, we demonstrate that induction of a mere 0.4 degrees C increase in skin temperature, whilst not altering core temperature, suppresses nocturnal wakefulness (P
Sleep, vigilance, and thermosensitivity. [2021]The regulation of sleep and wakefulness is well modeled with two underlying processes: a circadian and a homeostatic one. So far, the parameters and mechanisms of additional sleep-permissive and wake-promoting conditions have been largely overlooked. The present overview focuses on one of these conditions: the effect of skin temperature on the onset and maintenance of sleep, and alertness. Skin temperature is quite well suited to provide the brain with information on sleep-permissive and wake-promoting conditions because it changes with most if not all of them. Skin temperature changes with environmental heat and cold, but also with posture, environmental light, danger, nutritional status, pain, and stress. Its effect on the brain may thus moderate the efficacy by which the clock and homeostat manage to initiate or maintain sleep or wakefulness. The review provides a brief overview of the neuroanatomical pathways and physiological mechanisms by which skin temperature can affect the regulation of sleep and vigilance. In addition, current pitfalls and possibilities of practical applications for sleep enhancement are discussed, including the recent finding of impaired thermal comfort perception in insomniacs.
Modeling the long term effects of thermoregulation on human sleep. [2021]The connection between human sleep and energy exertion has long been regarded as part of the reasoning for the need to sleep. A recent theory proposes that during REM sleep, energy utilized for thermoregulation is diverted to other relevant biological processes. We present a mathematical model of human sleep/wake regulation with thermoregulatory functions to gain quantitative insight into the effects of ambient temperature on sleep quality. Our model extends previous models by incorporating equations for the metabolic processes that control thermoregulation during sleep. We present numerical simulations that provide a quantitative answer for how humans adjust by changing the normal sleep stage progression when it is challenged with ambient temperatures away from thermoneutral. We explore the dynamics for a single night and several nights. Our results indicate that including the effects of temperature is a vital component of modeling sleep.