Sleep Improvement Via Environmental Smart Temperature Adjustments

NCT06770400 | Active Not Recruiting

• 1 other identifier: Sleep and Temperature Study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Environmental Exposure; Environmental Sleep Disorder

Keywords

Temperature; Sleep; Older adults

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency Assessed by Actigraphy

  the ratio of time asleep to time in bed, measured using actigraphy, ranges from 0 (worse outcome) to 100% (better outcome).

  up to 8 weeks

Secondary Outcomes (3)

• Sleep Quality Assessed by a Questionnaire

  up to 8 weeks

• Sleep Duration Assessed by Actigraphy

  up to 8 weeks

• Sleep Onset Latency Assessed by Actigraphy

  up to 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Temperature Optimized for Sleep

Control

EXPERIMENTAL

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

Other: Participant's Preferred Temperature

Interventions

Temperature Optimized for Sleep OTHER

Using the cloud-controlled thermostat, we will prescribed bedroom temperature based on the observed relationship between the individual's sleep quality and the temperature of their bedroom.

Intervention

Participant's Preferred Temperature OTHER

Temperature is set by the individual based on their own habits and preference.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• At least 65 years old
• Willing to follow study protocols for the duration of the study
• Living in the greater Boston metropolitan area
• Access to stable internet connection within their home
• Stable medication
• Ability to speak and read English

You may not qualify if:

• Stated plans to not live within current place of residence for the duration of the study
• Inability to properly use the wearable device or complete the daily questionnaire.
• Self-report of physician-diagnosed sleep apnea or other diagnosed sleep disorders such as restless legs syndrome and chronic insomnia
• Inability to ambulate without the assistance of others
• Self- or proxy-report of physician-diagnosed dementia or overt neurological diseases such as Parkinson's Disease, stroke, or Multiple sclerosis
• Evidence of severe cognitive impairment defined as a Modified Telephone Interview of Cognitive Status (TICS-m) score \< 25
• Self-report of physician-diagnosed type 2 diabetes mellitus.
• 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)
• Self-report of any unstable psychiatric illnesses, such as major depressive disorder, schizophrenia, psychosis.
• Self-report of unstable medical conditions (active cancer, uncontrolled hypertension, unstable heart disease, heart attack within the past 6 months)

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew SeniorLife

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Dyssomnias

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amir Baniassadi

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: January 13, 2025
• Study Start: November 5, 2024
• Primary Completion: July 3, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)