SleepSleep-FASTNCT05652829
Sleep Duration and Quality in Children
An observational study of Sleep and Food Habits, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Obesity in children is a priority of public health initiatives, and reliable obesity prevalence and severity assessments are needed for policy decisions and study directions. Obesity in childhood raises the risk of insulin resistance, type 2 diabetes, and cardiovascular diseases in later life. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Food Habits, Lifestyle Factors
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The target population is recruited by advertising study directly and indirectly. Standard passive approaches are used, including flyers/posters on community bulletin boards, flyer handouts via afterschool programs, promotion on community radio stations, promotion via the Memorial University Newsline, and advertisements on research group websites and social media channels. Directed approaches are also used, including posting/messaging on age group-related parent Facebook groups with permission from group administrators, the Newfoundland and Labrador English School District are approached for permission to send information flyer out to all students in relevant grades in the St. John's and surrounding area.
Who may be able to join
- Age: 9-12 years old
- One parent or guardian should accompany the child.
- A commitment to complete all the questionnaires daily for both children and parents
- A commitment to wearing the actigraphy during seven days of study.
Who cannot join
- Remove the watch during the week of study
- Not completing two dietary recalls
- Not completing forms and questionnaires
- Being sick (e.g., Covid-19) during the week of study.
Trial locations and contacts
1 site in 1 country.
Scott Harding contact
Canada1 site, 1 recruiting
- Recruiting
Nutrition and Lifestyle Lab, Department of Earth Sciences, Memorial University of Newfoundland, 9 Arctic Ave
St. John's, Newfoundland and Labrador, A1B 3X5
Scott Harding, 709-864-8539 ext. +1, sharding@mun.ca
About this study
Official title: Sleep Duration and Quality in Children: Interactions With Food Choices, Energy Balance and Digital Screen-Time
Obesity in children is a priority of public health initiatives, and reliable obesity prevalence and severity assessments are needed for policy decisions and study directions. Obesity in childhood raises the risk of insulin resistance, type 2 diabetes, and cardiovascular diseases in later life. To develop preventive strategies, it is essential to identify modifiable lifestyle habits linked to childhood obesity. The four main modifiable lifestyle behaviors affecting body weight are physical activity, sleep, screen time, and eating patterns. Among these factors, sleep is a neglected issue for clinicians, and recent research has shown that sleep patterns can predict BMI and macronutrient intake. Getting enough sleep is essential to a person's physical and mental well-being and development. This study aims to determine the sleep duration and quality of children aged 9-12 during the school year and how sleep impacts food intake and choice. Also, determining any relationships between the sleep and food intake outcomes and screen time, physical activity, and anthropometric indicators.
Read the detailed description
Childhood obesity remains one of today's most significant public health challenges. Increased obesity among children has contributed to the rise in chronic diseases like obesity in adults, mental health issues, diabetes, cardiovascular disease, and cancer. Childhood obesity is complicated and multifaceted, involving genetic, endocrine causes, environmental, behavioral, and social factors. According to data, human sleep duration has declined rapidly over the past century. Sleep has recently been linked to cardiometabolic health, including obesity risk. The relationship between short sleep duration and body weight is stronger in children and decreases with age. Based on these findings, children may be more at risk of being overweight due to short sleep duration. A study in children aged 5-10 showed that short sleep duration is the most critical risk factor among other factors like parental obesity, more than 3 hours of television viewing, and physical inactivity for obesity and overweight. Sleep restriction was suggested to increase dietary intake, but there was no estimate of how much the increase in dietary intake could be due to restricted sleep. The shorter the sleeping duration (6 hours or less per night for adults), the more irregular the eating habits, the more frequent snacking between meals, the more salt used, and the fewer vegetables consumed. An intervention study showed that energy intake increased when sleep duration was restricted (1 night of 7 hours, two nights of 6 hours, and one night of 4 hours of sleep/night) compared to typical nights (2 nights of more than 8 hours of sleep/night). The rationale for the proposed study is that common lifestyle factors in children and adolescents, such as sedentary behavior, lack of physical activity, and increasing amounts of screen time, can each have independent and varying effects on the factors that affect the development of overweight and obesity. Therefore, a prospective study that objectively measures these lifestyle factors and the outcomes simultaneously and in real-time is needed to understand better the contribution of these lifestyle factors on changes in energy balance, sleep duration and quality, and food choices.
The primary objective of the proposed study is to determine the sleep duration and quality of children aged 9-12, both during the school year and over the summer school break, and how sleep impacts food intake and choices. The secondary objective is to determine any relationship between sleep and food intake outcomes, digital screen time, physical activity levels, and anthropometric indicators. The investigators hypothesize that insufficient sleep duration and low sleep quality would negatively affect lifestyle factors. This proposal aims to generate pilot, cross-sectional data for a future funding application to CIHR (Institute of Human Development, Child and Youth Health and/or Institute of Nutrition, Metabolism, and Diabetes) on implementing an interventional study. Implementation of an intervention study aimed at either increasing sleep duration, improving sleep hygiene, or reducing digital screen time. The study proposed here will help determine the feasibility of conducting a larger-scale cohort or interventional study and provide sufficient data to determine sample size requirements for such a study. This study will also help identify any critical aspects of the design that will need refinement before a full human trial can be undertaken.
The investigators are doing anthropometric measurements based on WHO procedures.
The investigators use the GENEActiv triaxial accelerometer (Activinsights Ltd, Cambs, UK) to objectively assess sleep duration, quality, and physical activity. Also, the investigators use CSHQ (Children's Sleep Habits Questionnaire), CRSP (Children's Report of Sleep patterns), ESS-CHAD (Epworth Sleepiness Scale for Children and Adolescents), and children's sleep diary for subjective data. Data on dietary habits are collected by completing two 24-hour recalls using the US National Cancer Institute web-based diet recording software called ASA24. In ASA24, the investigators can extract data concerning energy, macronutrient, micronutrient, and food groups like meat, dairy, vegetables, fruits, and carbohydrates.
A descriptive statistical analysis will be used to describe the demographic characteristics of the study sample. The investigators will report frequencies and percentages for categorical variables. A mean with standard deviations or a median with an interquartile range will be presented for continuous variables. The investigators will use Chi-square tests to test for differences between girls and boys. An individual's body mass index is calculated by dividing their weight (kg) by height (m2). There is a percentage error of 100 grams and 0.5 centimeters in weight and height. As a result of this calculation, values obtained will be converted into Z scores by the World Health Organization (WHO) growth curves. A binary logistic regression analysis will be conducted to assess the potential influence of sleep duration and quality on dietary habits. The odds ratios (OR) with confidence intervals (CI) will then be calculated and adjusted for confounding factors. A hierarchical binary logistic regression analysis will also be used to assess the potential effects of several demographic and lifestyle factors on sleep duration levels. An adjusted association between covariates will be calculated by calculating an OR with the 95% confidence interval and controlling for confounding. Statistics will be performed using SPSS version 28.0 for Windows (SPSS Inc., Chicago, Illinois, United States). It is decided that P = 0.05 will be the statistical significance level for two-sided hypotheses.
Actigraphy data: In GENEActiv version 3.3, acceleration data will be downloaded as raw binary files for the x,y, and z movement axes and saved in raw format. The accelerometer files will read into R and summarize using GGIR, version 1.5, without imputed values and using the ENMO metric.
In the 21st century, childhood obesity is one of the most important health challenges. It is possible to prevent obesity from escalating into severe psychosocial and somatic complications that could compromise normal growth and development when the disease is treated early. A practical first-line treatment approach is a family-based obesity intervention that addresses diet, physical activity, sedentary behavior, and sleep duration and quality and supports behavior change. Compared to the national average of 28 percent and most other regional health authorities, Newfoundland and Labrador have the greatest percentage of overweight and obese children (e.g., Eastern Health Region between 45 and 65%). This is the first study among Newfoundlander children examining the association between sleep duration and quality and lifestyle characteristics. The investigators are determining the sleep duration and quality of children aged 9-12 both during the school year and over the summer school break; also investigating the relationship between sleep duration and quality and food choices. Our study will also assess any relationship between sleep, screen time, physical activity, and food choices.
Based on our knowledge, this study is novel in some aspects: (A) Most previous studies on populations younger than nine years or above 12 years trying to avoid this age group. (B) This study assesses sleep and physical activity subjectively and objectively (questionnaires and actigraphy). (C) The investigators are trying to convince participants participating in the school phase to come back and partake in the study in the summertime to compare these two times. (D) Food habits is evaluated by the ASA24, which is one of the accurate methods for collecting food data. (E) Based on our knowledge, this study is one of the few studies that have been conducted that has measured the most important lifestyle factors together.
- Conditions
- Sleep, Food Habits, Lifestyle Factors
- Keywords
- Sleep, Food choice, Children, Screen time, Activity
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children aged 9-12 | We are recruiting 30 children aged 9-12 with one parent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration and quality
Questionnaires (sleep diary, Children's Sleep Habits Questionnaire, Epworth Sleepiness Scale for Children and Adolescents) and actigraphy (actigraphy is method of measuring human movement, activities and behaviours. It is normally worn on the wrist and measures temperature and environmental light as wellGENEActiv, Activinsights Ltd, Cambs, UK) will measure sleep parameters including total sleep time, bedtime, rise-time, sleep quality and efficiency, wake after sleep onset, sleep interruptions.
Measured: Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete a sleep diary every day from the first day of study.
Energy and sugar consumption
Two online 24-hour food recalls using Automated Self-Administered Dietary Assessment Tool(ASA24). ASA24 is a free web-based application that allows for numerous automatically coded self-administered 24-hour recalls and dietary records for epidemiologic, interventional, behavioural, or clinical research.
Measured: During seven days study, each participant complete two-24 recalls hour with their parents help. One should be on a weekday, and the other on the weekend during the study.
Secondary outcomes (2)
Physical activity levels
Questionnaires (physica activity questionnaire) and actigraphy (actigraphy is method of measuring human movement, activities and behaviours. It is normally worn on the wrist and measures temperature and environmental light as wellGENEActiv, Activinsights Ltd, Cambs, UK) will measure physical activity level including sedentary behavior, light, moderate and high activity.
Measured: Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete PAQ on the seventh day of the study.
Digital screen time
Screen time questionnaire will measure the amount of time each child spends and interacts with a digital device like a tablet, cellphone, or laptop, video games and TV.
Measured: Participants will complete questionnaire on the first day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Feb 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Harding, Memorial University of Newfoundland
- Investigators
- Scott Harding, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652829
- Sponsor's protocol ID
- 2021.228
- Other IDs
- 20222194
- Acronym
- Sleep-FAST
- Status last verified
- Dec 2022
- First submitted
- 1 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Duration and Quality in Children: Interactions With Food Choices, Energy Balance and Digital Screen-Time
- ClinicalTrials.gov ID
- NCT05652829
- Acronym / sponsor ID
- Sleep-FAST / 2021.228
- Conditions
- Sleep, Food Habits, Lifestyle Factors
- Keywords
- Sleep, Food choice, Children, Screen time, Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity in children is a priority of public health initiatives, and reliable obesity prevalence and severity assessments are needed for policy decisions and study directions. Obesity in childhood raises the risk of insulin resistance, type 2 diabetes, and cardiovascular diseases in later life. To develop preventive strategies, it is essential to identify modifiable lifestyle habits linked to childhood obesity. The four main modifiable lifestyle behaviors affecting body weight are physical activity, sleep, screen time, and eating patterns. Among these factors, sleep is a neglected issue for clinicians, and recent research has shown that sleep patterns can predict BMI and macronutrient intake. Getting enough sleep is essential to a person's physical and mental well-being and development. This study aims to determine the sleep duration and quality of children aged 9-12 during the school year and how sleep impacts food intake and choice. Also, determining any relationships between the sleep and food intake outcomes and screen time, physical activity, and anthropometric indicators.
Detailed description
Childhood obesity remains one of today's most significant public health challenges. Increased obesity among children has contributed to the rise in chronic diseases like obesity in adults, mental health issues, diabetes, cardiovascular disease, and cancer. Childhood obesity is complicated and multifaceted, involving genetic, endocrine causes, environmental, behavioral, and social factors. According to data, human sleep duration has declined rapidly over the past century. Sleep has recently been linked to cardiometabolic health, including obesity risk. The relationship between short sleep duration and body weight is stronger in children and decreases with age. Based on these findings, children may be more at risk of being overweight due to short sleep duration. A study in children aged 5-10 showed that short sleep duration is the most critical risk factor among other factors like parental obesity, more than 3 hours of television viewing, and physical inactivity for obesity and overweight. Sleep restriction was suggested to increase dietary intake, but there was no estimate of how much the increase in dietary intake could be due to restricted sleep. The shorter the sleeping duration (6 hours or less per night for adults), the more irregular the eating habits, the more frequent snacking between meals, the more salt used, and the fewer vegetables consumed. An intervention study showed that energy intake increased when sleep duration was restricted (1 night of 7 hours, two nights of 6 hours, and one night of 4 hours of sleep/night) compared to typical nights (2 nights of more than 8 hours of sleep/night). The rationale for the proposed study is that common lifestyle factors in children and adolescents, such as sedentary behavior, lack of physical activity, and increasing amounts of screen time, can each have independent and varying effects on the factors that affect the development of overweight and obesity. Therefore, a prospective study that objectively measures these lifestyle factors and the outcomes simultaneously and in real-time is needed to understand better the contribution of these lifestyle factors on changes in energy balance, sleep duration and quality, and food choices.
The primary objective of the proposed study is to determine the sleep duration and quality of children aged 9-12, both during the school year and over the summer school break, and how sleep impacts food intake and choices. The secondary objective is to determine any relationship between sleep and food intake outcomes, digital screen time, physical activity levels, and anthropometric indicators. The investigators hypothesize that insufficient sleep duration and low sleep quality would negatively affect lifestyle factors. This proposal aims to generate pilot, cross-sectional data for a future funding application to CIHR (Institute of Human Development, Child and Youth Health and/or Institute of Nutrition, Metabolism, and Diabetes) on implementing an interventional study. Implementation of an intervention study aimed at either increasing sleep duration, improving sleep hygiene, or reducing digital screen time. The study proposed here will help determine the feasibility of conducting a larger-scale cohort or interventional study and provide sufficient data to determine sample size requirements for such a study. This study will also help identify any critical aspects of the design that will need refinement before a full human trial can be undertaken.
The investigators are doing anthropometric measurements based on WHO procedures.
The investigators use the GENEActiv triaxial accelerometer (Activinsights Ltd, Cambs, UK) to objectively assess sleep duration, quality, and physical activity. Also, the investigators use CSHQ (Children's Sleep Habits Questionnaire), CRSP (Children's Report of Sleep patterns), ESS-CHAD (Epworth Sleepiness Scale for Children and Adolescents), and children's sleep diary for subjective data. Data on dietary habits are collected by completing two 24-hour recalls using the US National Cancer Institute web-based diet recording software called ASA24. In ASA24, the investigators can extract data concerning energy, macronutrient, micronutrient, and food groups like meat, dairy, vegetables, fruits, and carbohydrates.
A descriptive statistical analysis will be used to describe the demographic characteristics of the study sample. The investigators will report frequencies and percentages for categorical variables. A mean with standard deviations or a median with an interquartile range will be presented for continuous variables. The investigators will use Chi-square tests to test for differences between girls and boys. An individual's body mass index is calculated by dividing their weight (kg) by height (m2). There is a percentage error of 100 grams and 0.5 centimeters in weight and height. As a result of this calculation, values obtained will be converted into Z scores by the World Health Organization (WHO) growth curves. A binary logistic regression analysis will be conducted to assess the potential influence of sleep duration and quality on dietary habits. The odds ratios (OR) with confidence intervals (CI) will then be calculated and adjusted for confounding factors. A hierarchical binary logistic regression analysis will also be used to assess the potential effects of several demographic and lifestyle factors on sleep duration levels. An adjusted association between covariates will be calculated by calculating an OR with the 95% confidence interval and controlling for confounding. Statistics will be performed using SPSS version 28.0 for Windows (SPSS Inc., Chicago, Illinois, United States). It is decided that P = 0.05 will be the statistical significance level for two-sided hypotheses.
Actigraphy data: In GENEActiv version 3.3, acceleration data will be downloaded as raw binary files for the x,y, and z movement axes and saved in raw format. The accelerometer files will read into R and summarize using GGIR, version 1.5, without imputed values and using the ENMO metric.
In the 21st century, childhood obesity is one of the most important health challenges. It is possible to prevent obesity from escalating into severe psychosocial and somatic complications that could compromise normal growth and development when the disease is treated early. A practical first-line treatment approach is a family-based obesity intervention that addresses diet, physical activity, sedentary behavior, and sleep duration and quality and supports behavior change. Compared to the national average of 28 percent and most other regional health authorities, Newfoundland and Labrador have the greatest percentage of overweight and obese children (e.g., Eastern Health Region between 45 and 65%). This is the first study among Newfoundlander children examining the association between sleep duration and quality and lifestyle characteristics. The investigators are determining the sleep duration and quality of children aged 9-12 both during the school year and over the summer school break; also investigating the relationship between sleep duration and quality and food choices. Our study will also assess any relationship between sleep, screen time, physical activity, and food choices.
Based on our knowledge, this study is novel in some aspects: (A) Most previous studies on populations younger than nine years or above 12 years trying to avoid this age group. (B) This study assesses sleep and physical activity subjectively and objectively (questionnaires and actigraphy). (C) The investigators are trying to convince participants participating in the school phase to come back and partake in the study in the summertime to compare these two times. (D) Food habits is evaluated by the ASA24, which is one of the accurate methods for collecting food data. (E) Based on our knowledge, this study is one of the few studies that have been conducted that has measured the most important lifestyle factors together.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 9-12 | – | –We are recruiting 30 children aged 9-12 with one parent. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The target population is recruited by advertising study directly and indirectly. Standard passive approaches are used, including flyers/posters on community bulletin boards, flyer handouts via afterschool programs, promotion on community radio stations, promotion via the Memorial University Newsline, and advertisements on research group websites and social media channels. Directed approaches are also used, including posting/messaging on age group-related parent Facebook groups with permission from group administrators, the Newfoundland and Labrador English School District are approached for permission to send information flyer out to all students in relevant grades in the St. John's and surrounding area.
Key inclusion criteria (4 listed)
- Age: 9-12 years old
- One parent or guardian should accompany the child.
- A commitment to complete all the questionnaires daily for both children and parents
- A commitment to wearing the actigraphy during seven days of study.
Key exclusion criteria (4 listed)
- Remove the watch during the week of study
- Not completing two dietary recalls
- Not completing forms and questionnaires
- Being sick (e.g., Covid-19) during the week of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep duration and quality
Time frame: Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete a sleep diary every day from the first day of study.
Questionnaires (sleep diary, Children's Sleep Habits Questionnaire, Epworth Sleepiness Scale for Children and Adolescents) and actigraphy (actigraphy is method of measuring human movement, activities and behaviours. It is normally worn on the wrist and measures temperature and environmental light as wellGENEActiv, Activinsights Ltd, Cambs, UK) will measure sleep parameters including total sleep time, bedtime, rise-time, sleep quality and efficiency, wake after sleep onset, sleep interruptions.
Energy and sugar consumption
Time frame: During seven days study, each participant complete two-24 recalls hour with their parents help. One should be on a weekday, and the other on the weekend during the study.
Two online 24-hour food recalls using Automated Self-Administered Dietary Assessment Tool(ASA24). ASA24 is a free web-based application that allows for numerous automatically coded self-administered 24-hour recalls and dietary records for epidemiologic, interventional, behavioural, or clinical research.
2 secondary outcomes
Physical activity levels
Time frame: Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete PAQ on the seventh day of the study.
Digital screen time
Time frame: Participants will complete questionnaire on the first day of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Harding contact
Scott Harding principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Food Habits, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Harding (709-864-8539 ext. +1, sharding@mun.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration and quality (time frame: Participants wear the actigraphy for seven days. When the researcher fits the participant with actigraphy, it collects data until seven days based on the researcher sitting. Participants will complete a sleep diary every day from the first day of study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.