Sleep Quality
Conditions
Keywords
Pregnancy, intervention, Sleep quality, personal ambient temperature exposure
Brief summary
The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in pregnant women. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index? Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Pittsburgh Sleep Quality Index questionnaire in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.
Interventions
OTHERHeat intervention
The participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools to be developed by the project research team
The participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces.
Sponsors
University of Cyprus
Azienda ospedaliera Garibaldi Catania
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized into three parallel study groups to a) receive no alerts for high temperatures nor recommendations for mitigation of health effects (business as usual scenario, control group), b) receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and or A/C devices, as well as recommendations for mitigation of health effects (hydration, body cooling) in written and animated format, through mobile phone and web application tools (heat mitigation intervention), and c) receive alerts and recommendations as in group (b) and in addition continuously use air cleaners with HEPA filter for removing PM from indoor air in their residences (heat and air pollution mitigation intervention)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant Women (PW) aged 20 to 35 years * being in the 2nd trimester of a singleton pregnancy (15th-27th week of gestation) * Living in Catania (Italy) or Limassol (Cyprus) districts * Clinically healthy * No Gestational diabetes * No pre-eclampsia * No severe pregnancy complications
Exclusion criteria
* Currently smoking * Presence of any smoking residents in the household * Not residing at the household for at least 5 days a week * Planning to move from the current home within the next two months * No access to Wi-Fi or 4G/5G mobile phone * Severe chronic conditions (congestive heart failure, ischemic heart disease, significant valvular heart disease, DM2, inflammatory diseases, renal failure, or active cancer) * Drugs abuse * Alcohol abuse * Psychiatric disorders * Severe mental disability that interferes with answering questions or following instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep-wake pattern | Daily measurements - for the whole duration of follow-up (2 months) | Sleep-wake pattern will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband). |
| Sleep-Wake self-reported evaluation | The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | The sleep-wake self-reported evaluation will be carried out using a predefined sleep diary which will be completed by the participant on the morning after he/she wakes up. Each assessment of sleep-wake self-reported evaluation will be carried out for a whole week. |
| Hamilton Anxiety Rating Scale | The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | The Hamilton Anxiety Rating Scale will be carried out to assess the severity of a person's anxiety. The Hamilton Anxiety Rating Scale ranges from 0 to 56, where higher scores indicate greater anxiety severity. The scoring is divided into severity tiers: \<17 (mild), 18-24 (mild to moderate), and 25-56 (moderate to severe). The scale consists of 14 items, each rated from 0 to 4 points. It evaluates both psychic anxiety (e.g., tension, fears, mood) and somatic anxiety (physical complaints). |
| Daily heart rate | Daily measu.ments - for the whole duration of follow-up (2 months) . | Heart rate measurements taken throughout the day by a wearable device (wristband). |
| Systolic/Diastolic Blood Pressure | Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Measurements of Systolic/Diastolic Blood Pressure will be recorded. |
| Heart Rate | Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Heart rate will be measured using ECG. |
| Heart Rate Variability | The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Heart rate variability will be measured using ECG. |
| Serum C-reactive Protein Levels | Serum levels of C-reactive protein will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum levels of C-reactive protein (mg/L), as a marker of systemic inflammation, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Serum Urea Levels | Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum levels of urea (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Serum Creatinine Levels | Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Serum Sodium levels | Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Serum Potassium Levels | Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Serum Osmolality | Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Serum osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Urine Creatinine Levels | Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Urine levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Urine Sodium levels | Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Urine levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Urine Potassium levels | Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Urine levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Urine Osmolality | Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months). | Urine osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| The personal ambient temperature profile of all participants | Daily measurements - for the whole duration of follow-up (2 months) | Personal exposures of participants will be monitored continuously during the two observation months with wearable sensors to be always worn and assess personal exposure to ambient (indoor and outdoor) temperature (iButton). |
| Wet-bulb globe temperature (WGBT) | Daily measurements - for the whole duration of follow-up (2 months). | Wet-bulb globe temperature, will be assessed as a thermal stress indicator. |
| Humidity | Daily measurements - for the whole duration of follow-up (2 months). | Humidity will be measured using iButton. |
| Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at residence | Daily measurements - for the whole duration of follow-up (2 months). | Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense). |
| Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at work | Daily measurements - for the whole duration of follow-up (2 months). | Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' work place will be measured continuously indoors using commercial lightweight sensors (Alpha sense). |
| Indoor concentration levels of Particulate Matter 10 (PM 10) at residence | Daily measurements - for the whole duration of follow-up (2 months). | Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense). |
| Indoor concentration levels of Particulate Matter 10 (PM 10) at work | Daily measurements - for the whole duration of follow-up (2 months). | Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' work place will be measured continuously indoors using commercial lightweight sensors (Alpha sense). |
| Number of daily steps | Daily measurements - for the whole duration of follow-up (2 months) | Number of daily steps will be measured throughout the day by a wearable device (wristband). |
| Hair cortisol levels | Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months) | Hair cortisol levels (pg/mg), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
| Saliva alpha-amylase levels | Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months) | Saliva levels of alpha-amylase (U/mL), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months). |
Countries
Cyprus, Italy
Contacts
CONTACTPanayiotis Yiallouros, Professor
CONTACTPanayiotis Kouis, PhD
PRINCIPAL_INVESTIGATORPanayiotis Yiallouros, Professor
University of Cyprus
Outcome results
None listed