Temperature Optimization for Sleep

(SIESTA Trial)

Overseen By Peyton Berning

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Disqualifiers: Sleep disorders, Dementia, Diabetes, Neurological diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adjusting bedroom temperature can improve sleep quality in older adults. Participants will wear health trackers, and a smart thermostat will automatically adjust their bedroom temperature using a system called Biologically Adaptive Control of Bedroom Temperature to find the optimal temperature for sleep. The trial aims to determine the feasibility and effectiveness of this approach. It seeks participants aged 65 and over who reside in the greater Boston area and have stable internet and heating/cooling systems. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep quality for older adults.

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.

What prior data suggests that biologically adaptive control of bedroom temperature is safe for improving sleep in older adults?

Research has shown that maintaining the right bedroom temperature can help older adults sleep better. This method involves no drugs or surgeries, so the risks remain very low. One study found that using gadgets like wearable devices and smart thermostats to adjust bedroom temperature can improve sleep. This approach simply adjusts the room's temperature based on the body's needs.

Since this involves changing the environment, it avoids side effects associated with medications. If discomfort arises, individuals can adjust the thermostat settings themselves, ensuring comfort remains a priority. This makes the method easy to manage and minimizes the risk of problems.

In summary, this approach is safe because it focuses on comfort and individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Temperature Optimization for Sleep trial because it explores a new approach to enhancing sleep quality by adjusting bedroom temperatures based on biological needs. Unlike current sleep aids, which often involve medications or cognitive-behavioral techniques, this trial seeks to optimize the sleeping environment itself. The innovative aspect is the biologically adaptive control, allowing temperatures to be tailored specifically for individual sleep patterns, potentially improving sleep without the need for pills or extensive therapy. This personalized method could revolutionize how we approach sleep disturbances, offering a non-invasive and customizable alternative to standard treatments.

What evidence suggests that biologically adaptive control of bedroom temperature is effective for improving sleep in older adults?

Research has shown that sleep is best when the bedroom temperature is between 68 and 77 degrees Fahrenheit (20–25°C). One study found that sleep quality dropped by 5–10% when temperatures exceeded this range. This trial will test the Biologically Adaptive Control of Bedroom Temperature. The experimental group will have their bedroom temperature set to the optimal level for sleep, with the option to override the prescribed temperature. Meanwhile, the control group will manage their own bedroom temperature. Smart thermostats and health trackers can help maintain the right temperature, potentially improving sleep quality for older adults without high costs or side effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Amir Baniassadi

Principal Investigator

Hebrew SeniorLife

Are You a Good Fit for This Trial?

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

My medication doses have not changed recently.

Ability to speak and read English

Willing to follow study protocols for the duration of the study

Exclusion Criteria

Stated plans to not live within current place of residence for the duration of the study

Lack of a thermostat-controlled heating and cooling system to adjust the bedroom temperature. The existing system must be compatible with the thermostat selected in this study (Ecobee)

Evidence of severe cognitive impairment defined as a Modified Telephone Interview of Cognitive Status (TICS-m) score < 25

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Observation

Participants sleep at their self-selected temperatures to gather baseline data

2 weeks

Daily monitoring (remote)

Intervention

Temperature adjustments are made to determine optimal sleep conditions

4 weeks

Daily monitoring (remote)

Experiment

Participants are divided into control and experimental groups to test optimal temperature settings

2 weeks

Daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biologically Adaptive Control of Bedroom Temperature

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Experimental Treatment 1 Intervention

After the initial monitoring, the control group will control their own bedroom temperature.

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

Published Research Related to This Trial

In a study involving six male subjects, sleep was significantly disrupted at temperatures below thermoneutrality (29°C), with 21°C being the most disruptive, indicating that colder temperatures negatively impact sleep quality.

The research found that both cold and warm temperatures outside the thermoneutral range similarly affected sleep patterns, suggesting that disruptions in REM sleep are likely due to general sleep process disturbances rather than specific thermoregulatory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of high and low ambient temperatures on human sleep stages. Haskell, EH., Palca, JW., Walker, JM., et al.[2019]

A study involving eight healthy subjects showed that warming the skin can significantly reduce the time it takes to fall asleep, with a 26% decrease in sleep-onset latency when skin temperature was increased by just 0.78 degrees Celsius.

This research provides experimental evidence that skin temperature changes can directly influence sleep onset, suggesting that managing skin temperature could be a potential strategy for improving sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous warming promotes sleep onset. Raymann, RJ., Swaab, DF., Van Someren, EJ.[2022]

A new mathematical model shows that ambient temperature significantly affects sleep quality by altering the normal progression of sleep stages, particularly during REM sleep.

The model incorporates thermoregulatory functions, providing insights into how humans adjust their sleep patterns in response to temperatures outside the comfortable range, highlighting the importance of temperature in sleep regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling the long term effects of thermoregulation on human sleep. Bañuelos, S., Best, J., Huguet, G., et al.[2021]

Skin temperature plays a significant role in regulating sleep and alertness, as it provides the brain with crucial information about sleep-permissive and wake-promoting conditions.

The review highlights the neuroanatomical pathways and physiological mechanisms through which skin temperature influences sleep regulation, suggesting potential applications for enhancing sleep, especially in individuals with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, vigilance, and thermosensitivity. Romeijn, N., Raymann, RJ., Møst, E., et al.[2021]

A slight increase of just 0.4 degrees Celsius in skin temperature during sleep significantly reduced wakefulness and enhanced deep sleep stages in both young and elderly participants, with particularly strong effects observed in the elderly.

This method of skin warming could effectively address common sleep issues in older adults, such as reduced slow wave sleep and early morning awakenings, suggesting a promising non-invasive approach to improve sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin deep: enhanced sleep depth by cutaneous temperature manipulation. Raymann, RJ., Swaab, DF., Van Someren, EJ.[2019]

Controlling bed temperature at a steady 32°C improved the amount of slow-wave sleep (SWS) in subjects, indicating that a comfortable sleep environment can enhance sleep quality.

Dynamic temperature adjustments that cool the bed during REM sleep and heat it during SWS led to an increased share of REM sleep, suggesting that optimal temperature settings may vary between different sleep stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic Study for Optimal Control of In-Bed Temperature during Sleep. Okada, S., Suzuki, S., Fukui, T., et al.[2020]

The study explores the relationship between body temperature and sleep, suggesting that changes in temperature may directly influence brain areas responsible for initiating sleep, indicating a potential causative link rather than just a coincidence.

Emerging evidence supports a model where thermoregulatory changes provide signals to the brain that help regulate sleep and wakefulness, potentially creating a feedback loop that maintains consolidated sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermoregulation as a sleep signalling system. Gilbert, SS., van den Heuvel, CJ., Ferguson, SA., et al.[2022]

Whole body heating in rats, achieved by raising ambient temperature to 33-35 degrees C, significantly increased deep non-rapid eye movement sleep (NREMS2) during the first two hours of recovery compared to baseline and sleep-matched controls, suggesting a potential method to enhance sleep quality.

The study also found that brain temperature (Tbr) was lower for several hours following heating, indicating a possible link between body temperature regulation and sleep patterns, although rapid eye movement sleep did not show significant changes compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective increases in non-rapid eye movement sleep following whole body heating in rats. Morairty, SR., Szymusiak, R., Thomson, D., et al.[2019]

The developed temperature regulation system for small mammals can precisely control body temperature during neurophysiological experiments, reacting to temperature differences as small as 0.001 degrees Celsius without introducing recording artifacts.

This innovative system, which uses a flexible, insulated blanket, has potential clinical applications, suggesting it could be beneficial for maintaining stable body temperatures in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system with some unique features for maintaining desired body temperature in anesthetized and/or immobilized animals. Shipley, MT., Graf, M.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0360132325005281

Impacts of thermal adaptive behaviors in bedrooms on ... This study examined how thermal adaptive behaviors in bedrooms, specifically air conditioning (AC) use, adjustments of sleepwear and bedding insulation, affect ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06770400

Study Details | NCT06770400 | Sleep Improvement Via ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529213/

Nighttime Ambient Temperature and Sleep in Community ... Our findings demonstrated that sleep was most efficient and restful when nighttime ambient temperature ranged between 20–25°C, with a clinically relevant 5–10% ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666123323000570

A review of human body temperature, sleeping thermal ... This review took body temperature distribution as a bridge for the connection of sleep quality and sleeping thermal comfort.

5. hebrewseniorlife.org hebrewseniorlife.org/news/optimal-sleep-temperature-seniors-between-68-77-degrees-fahrenheit-study-reveals

Optimal Sleep Temperature for Seniors Is Between 68 to ... The authors observed an overall trend: a 5-10% drop in sleep efficiency as the nighttime ambient temperature increases from 77 to 86 Fahrenheit.

6. mdpi.com mdpi.com/2073-4433/14/12/1782

Bedrooms and the Vulnerability of Sleepers to Extreme ... It highlights the vulnerability of sleepers and the need for adaptation strategies to cope with extreme heat events without resorting to mechanical air ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0160412025002946

Exposure to high temperature and sleep in preadolescents ... Warmer temperatures were associated with shortened sleep duration and poorer sleep efficiency in adolescents in the Netherlands, but not in Spain.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/01436244231183113

An overheating criterion for bedrooms in temperate climates A new overheating criterion is proposed to identify overheated bedrooms. It adopts the familiar format of a temperature threshold and an allowable exceedance.