None listed
Conditions
Brief summary
Sleep is regulated via a homeostatic need for sleep and circadian biology, which is now well understood to involve light-sensory neuro-hormonal signalling to intracellular clock mechanisms throughout the body. Despite major advances in the mechanistic understanding of the body-clock system, practical methods for daily circadian tracking do not exist. This pilot trial aims at testing and refining the first high performance hybrid wearable-sensor integrated with circadian physiology and data driven analysis methods needed for daily circadian rhythm tracking in healthy adult sleepers and adults with sleep disorders. Participants will be wearing wrist-, chest-, and neck-worn monitors, and using a mattress and bedside sensor and monitoring device, to capture a range of physiological signals, such as skin and core body temperature, physical activity, heart rate, and ambient light exposure data in 3 days (72 hours). They will also be ingesting capsules which contain a temperature sensor and a wireless transmitter to record core body temperature (about 1 capsule ingested per day). Data generated will be used to refine current analytical methods to separate small circadian from much larger activity and exercise effects on core body temperature.
Interventions
This pilot trial aims at testing and refining the first high performance hybrid wearable-sensor integrated with circadian physiology and data driven analysis methods needed for daily circadian rhythm tracking in healthy adult sleepers and adults with sleep disorders. Participants will be wearing wrist-, chest-, and neck-worn monitors to capture a range of physiological signals, such as skin and core body temperature, physical activity, heart rate, and ambient light exposure data in 3 days (72 hours). They will be provided with a mattress and bedside sensor and monitoring device which will be placed on their mattresses to capture body position and breathing signals while asleep. Participants will ingest capsules which contain a temperature sensor and a wireless transmitter to record core body temperature (about 1 capsule ingested per day). They will also be asked to log their sleep and activities while at home and complete smartphone-administered cognitive performance tests each morning and evening during this time. On the third day of the trial, participants will collect saliva samples for dim light melatonin onset (DLMO) assessment, with appropriate instructions provided by the research team beforehand. Serial salivary samples will be collected every 30 minutes by participants themselves in dimly lit home environment from 5 hours before to 2 hours after their normal bedtime, i.e., 7 hours in total. DLMO assessment is the gold standard for measuring circadian timing and will be used as a comparison against the core body temperature data collected by the wearable devices. To assess adherence, we will review participants' daily usage of devices and their daily logs of sleep and activities, and examine the degree of data loss from each device and the integrity of the physiological signals they collect. Similarly, the completion rate of the cognitive performance tasks will be assessed. Data generated will be used to refine current analytical methods to separate small circadian from much larger activity and exercise effects on core body temperature.
Sponsors
Study design
Eligibility
Inclusion criteria
- Aged 18 years or older - Safe to ingest core body temperature capsules (see Key Exclusion Criteria for contraindications)
Exclusion criteria
- Language difficulties that may preclude informed consent. - Any severe cognitive impairments, mental illnesses, or intellectual disabilities that may preclude informed consent. - Any physical disability that may significantly impact movement. - Any heart related disease. - Any tattoos or other applied colouring to the skin, either on both wrists, or on the anterior chest. - Any constraints that would prevent wearing devices on the wrists or chest for any continuous period of longer than 2 hours, such as particular daily activities, vocational requirements (e.g., bare wrists, device restrictions), etc. - Having a variable bedtime that changes from day to day with a difference of 2 hours or more between the bedtimes between days. - Contraindications for core body temperature capsule ingestion, including: 1. Body-mass index less than 18.5 kg/m² or greater than 32.9 kg/m²; 2. Being pregnant or lactating; 3. Having a pacemaker or electro-medical implant; 4. Having a risk of intestinal disorders; 5. Having a history of diverticula; 6. Having a history of GI tract surgical procedures; 7. Having known swallowing disorders; 8. Suffering with Crohn’s Disease; or 9. Will be requiring an MRI between the day of ingesting the first capsule and 7 days after ingesting the last capsule.