Quality Sleep TimeNCT01364831
Connection Between Sleep and Athletic Performance
A study testing Sleep extension in people with Quality Sleep Time and Athletic Performance, run by Wingate Institute at 1 site in Israel.
Trial summary
In the last few decades much knowledge has been accumulated on the connection between healthy, sufficient sleep and overall health, cognitive function, memory and job or school performance, motor vehicle accidents and work accidents. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality Sleep Time, Athletic Performance
- What is being tested?
- Sleep extension
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Nov 2012
- Phase
- Interventional
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 13-20 years old, male and female
- Generally good health
- Willingness to participate in the study
- Healthy heart rate
Who cannot join
- Arrhythmia
- Chronic or acute illness
- Unwillingness of the subject or his/her parents to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Connection Between Sleep Quality and Duration and Performance in Young Athletes
In the last few decades much knowledge has been accumulated on the connection between healthy, sufficient sleep and overall health, cognitive function, memory and job or school performance, motor vehicle accidents and work accidents. There has been growing awareness recently of the connection between physical activity and competitive sports performance, and the amount and quality of sleep. Despite the dearth of scientific studies, there is a constant effort to improve understanding in this field.
An appropriate procedure designed to evaluate the influence of the quality and amount of sleep on ability and athletic performance must fulfill a number of basic requirements:
Read more
- Isolating the influence of components related to sleep homeostasis and factors relating to circadian rhythm.
- Neutralizing as much as possible the influence of motivation on the evaluation - one must presumably include a significant competitive event (it is not always possible to do a simple extrapolation between physiological measurements and competitive performance).
- Isolating and canceling as much as possible additional factors affecting performance, such as: home advantage, weather, injury and field conditions.
Athletic activity includes not just competitions but also training towards competitions, since it is difficult to control for influences of competitions and other occasional events, in this study the investigators focus on evaluation of the connection between sleep and athletic performance in training.
Towards the end of adolescence, youth are busy in multiple activities related to studies, social obligations and athletic activity. This is also the age they learn to drive. This is an age in which physiologically a person needs more sleep relative to at other ages (9.25 hours of sleep a day), and paradoxically due to the multiple obligations the amount of sleep is lower than needed.
Beyond the effect on mood, cognitive performance and memory, sleep deprivation causes far-reaching changes in multiple systems, such as:
Cardiovascular System:
- Many studies show that shortened sleep duration constitutes an independent cause of increased cardiac events.
- Resting heart rate and maximum heart rate decrease after 30 hours of sleep deprivation.
Respiratory System:
- Significant decline in respiratory function as measured by: FVC, Maximal voluntary ventilation, Maximal static inspiratory/expiratory pressures, Time to exhaustion with exercise, Peak O2 consumption, Peak CO2 production.
- Worsening of respiratory sleep disturbances.
Digestive System:
- Changes in food consumption accompanied by changes in body weight.
Neurophysiological System
- Disturbance of thermoregulation.
Endocrine System:
- Hormonal changes associated with hypothalamic-hypophyseal axis
- Influence on secretion of Ghrelin and leptin
- Influence on secretion of growth hormone.
In light of this, there is sound basis for the presumption that athletic performance is connected to these influences directly and indirectly.
The purpose of this study is to evaluate the connection between sleep quality and duration and athletic performance among young athletes living and training at the Sport-Gifted Centre at the Wingate Institute.
Read the detailed description
Aim The purpose of this study is to evaluate the connection between sleep quality and duration and athletic performance among young athletes living and training at the Sport-Gifted Centre at the Wingate Institute.
Methods 50 athletes of the Sport-Gifted Centre at the Wingate Institute, ages 13-20, male and female, from the branches of triathlon and swimming. Participants and their parents will be asked to give informed consent.
The proposed study will have two stages:
- Baseline assessment: In the first stage there will be an evaluation of sleep quality and duration of the athletes over the course of two weeks, in parallel their athletic performance will be evaluated using accepted measures such as: swimming times over set distances, running times over set distances, etc.
- Assessment of intervention's effect of prolonging the duration of nighttime sleep on the athletic performance of the participants, using the same measures as above. This stage will take four weeks.
Stage 1:
Before beginning the study each participant will fill out a general health questionnaire.
Each participant will receive a Suunto heart monitor belt to sleep with for two weeks. Each participant will be asked to wear the belt before going to bed and take it off upon waking up in the morning. Heart rate data stored on the belts will be transferred each morning to a computer. Analysis of sleep architecture and duration over the course of the two weeks will be carried out using the HC1000P system from HypoCore Inc. (see attached documents). In addition average heart rate and maximal heart rate can be assessed while training at baseline by recording heart rate using the Suunto belts. Sleep data will be analyzed and each participant will receive a personalized analysis of his/her sleep. At this stage the investigators will evaluate the baseline characteristics of the participants including sleep duration, sleep efficiency, presence and duration of the different sleep stages, in particular slow wave sleep during which it is known a growth factor is released which is important for muscle recovery, times and durations of training sessions and athletic performance.
Evaluation of athletic performance will be done using standard tests that are routinely carried out as part of the athletes' training program in every branch of sports. For triathletes running times for 3000 meters are measured, for swimmers their times for set distances (50 meters,100 meters, 400 meters, etc). All these measures will be done without deviation from the regular training routine. Also general parameters will be measured like standing heart rate and reclining heart rate, and heart rate at awakening in the morning.
Stage 2:
At this stage the participants will be divided randomly into two groups. In the course of an additional training cycle of two weeks one group labeled 'A' will be given additional sleep time of one to two hours. The second group (group 'B') shall continue with no change. In the course of the two weeks sleep parameters of both groups will be assessed and analyzed, and athletic performance during routine training will continue to be measured and tabulated. After these two weeks the two groups will be crossed over, group 'A' will return to a routine sleep schedule, i.e. the extra sleep time will be removed and group 'B' will get additional sleep time. All the aforementioned measures will be collected during two weeks (sleep quality, athletic performance during training).
After analysis of the results further testing will be recommended as needed as well as changes in training programs, daily scheduling and sleep schedules.
During the entire study there will be close monitoring of injuries among participants. Events will be defined as injuries (according to the number of treatments by a physiotherapist or visits to a doctor) or near injuries and will be quantified, and correlations will be sought between performance, injuries and sleep duration.
In both stages in addition to wearing a heart rate belt, the participants will be asked to fill out a questionnaire before and after sleep during the entire study (see attached document).
Note: Suunto is a Finnish company that makes advanced sports watches and sensitive heart rate belts used by athletes in their training. The belt is soft, of very high quality, lightweight and contains a sensor and memory unit to store the heart rate data of the participant. It is approved for routine use for monitoring heart rate in people engaged in physical activity.
Expected benefits:
- Better understanding of the physiology associated with sleep among adolescents involved in regular, competitive physical activity.
- Improved performance by building a sleep program, optimal wakefulness and training.
- Conditions
- Quality Sleep Time, Athletic Performance
- Being tested
- Sleep extension
- Keywords
- sleep time, athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
Athletic performance evaluated at baseline and following about 1.5 hours of sleep extension
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved athletic performance: reduced swimming and running times over predefined distances with sleep extension
Measure the changes in performance (running and swimmimng time) as follows: for runners- time required for 3000 m distance. for swimmers- time required for 50 m, 100 m, and 400 m, at predefined heart rates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality Sleep TimeStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wingate Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eyal Shargal, Wingate Institute
- Investigators
- Eyal Shargal, PhD, Principal investigator, Wingate Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364831
- Sponsor's protocol ID
- WingateHC1
- Status last verified
- Dec 2013
- First submitted
- 29 Mar 2011
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connection Between Sleep Quality and Duration and Performance in Young Athletes
- ClinicalTrials.gov ID
- NCT01364831
- Acronym / sponsor ID
- WingateHC1
- Conditions
- Quality Sleep Time, Athletic Performance
- Keywords
- sleep time, athletic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wingate InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- 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.
In the last few decades much knowledge has been accumulated on the connection between healthy, sufficient sleep and overall health, cognitive function, memory and job or school performance, motor vehicle accidents and work accidents. There has been growing awareness recently of the connection between physical activity and competitive sports performance, and the amount and quality of sleep. Despite the dearth of scientific studies, there is a constant effort to improve understanding in this field.
An appropriate procedure designed to evaluate the influence of the quality and amount of sleep on ability and athletic performance must fulfill a number of basic requirements:
- Isolating the influence of components related to sleep homeostasis and factors relating to circadian rhythm.
- Neutralizing as much as possible the influence of motivation on the evaluation - one must presumably include a significant competitive event (it is not always possible to do a simple extrapolation between physiological measurements and competitive performance).
- Isolating and canceling as much as possible additional factors affecting performance, such as: home advantage, weather, injury and field conditions.
Athletic activity includes not just competitions but also training towards competitions, since it is difficult to control for influences of competitions and other occasional events, in this study the investigators focus on evaluation of the connection between sleep and athletic performance in training.
Towards the end of adolescence, youth are busy in multiple activities related to studies, social obligations and athletic activity. This is also the age they learn to drive. This is an age in which physiologically a person needs more sleep relative to at other ages (9.25 hours of sleep a day), and paradoxically due to the multiple obligations the amount of sleep is lower than needed.
Beyond the effect on mood, cognitive performance and memory, sleep deprivation causes far-reaching changes in multiple systems, such as:
Cardiovascular System:
- Many studies show that shortened sleep duration constitutes an independent cause of increased cardiac events.
- Resting heart rate and maximum heart rate decrease after 30 hours of sleep deprivation.
Respiratory System:
- Significant decline in respiratory function as measured by: FVC, Maximal voluntary ventilation, Maximal static inspiratory/expiratory pressures, Time to exhaustion with exercise, Peak O2 consumption, Peak CO2 production.
- Worsening of respiratory sleep disturbances.
Digestive System:
- Changes in food consumption accompanied by changes in body weight.
Neurophysiological System
- Disturbance of thermoregulation.
Endocrine System:
- Hormonal changes associated with hypothalamic-hypophyseal axis
- Influence on secretion of Ghrelin and leptin
- Influence on secretion of growth hormone.
In light of this, there is sound basis for the presumption that athletic performance is connected to these influences directly and indirectly.
The purpose of this study is to evaluate the connection between sleep quality and duration and athletic performance among young athletes living and training at the Sport-Gifted Centre at the Wingate Institute.
Detailed description
Aim The purpose of this study is to evaluate the connection between sleep quality and duration and athletic performance among young athletes living and training at the Sport-Gifted Centre at the Wingate Institute.
Methods 50 athletes of the Sport-Gifted Centre at the Wingate Institute, ages 13-20, male and female, from the branches of triathlon and swimming. Participants and their parents will be asked to give informed consent.
The proposed study will have two stages:
- Baseline assessment: In the first stage there will be an evaluation of sleep quality and duration of the athletes over the course of two weeks, in parallel their athletic performance will be evaluated using accepted measures such as: swimming times over set distances, running times over set distances, etc.
- Assessment of intervention's effect of prolonging the duration of nighttime sleep on the athletic performance of the participants, using the same measures as above. This stage will take four weeks.
Stage 1:
Before beginning the study each participant will fill out a general health questionnaire.
Each participant will receive a Suunto heart monitor belt to sleep with for two weeks. Each participant will be asked to wear the belt before going to bed and take it off upon waking up in the morning. Heart rate data stored on the belts will be transferred each morning to a computer. Analysis of sleep architecture and duration over the course of the two weeks will be carried out using the HC1000P system from HypoCore Inc. (see attached documents). In addition average heart rate and maximal heart rate can be assessed while training at baseline by recording heart rate using the Suunto belts. Sleep data will be analyzed and each participant will receive a personalized analysis of his/her sleep. At this stage the investigators will evaluate the baseline characteristics of the participants including sleep duration, sleep efficiency, presence and duration of the different sleep stages, in particular slow wave sleep during which it is known a growth factor is released which is important for muscle recovery, times and durations of training sessions and athletic performance.
Evaluation of athletic performance will be done using standard tests that are routinely carried out as part of the athletes' training program in every branch of sports. For triathletes running times for 3000 meters are measured, for swimmers their times for set distances (50 meters,100 meters, 400 meters, etc). All these measures will be done without deviation from the regular training routine. Also general parameters will be measured like standing heart rate and reclining heart rate, and heart rate at awakening in the morning.
Stage 2:
At this stage the participants will be divided randomly into two groups. In the course of an additional training cycle of two weeks one group labeled 'A' will be given additional sleep time of one to two hours. The second group (group 'B') shall continue with no change. In the course of the two weeks sleep parameters of both groups will be assessed and analyzed, and athletic performance during routine training will continue to be measured and tabulated. After these two weeks the two groups will be crossed over, group 'A' will return to a routine sleep schedule, i.e. the extra sleep time will be removed and group 'B' will get additional sleep time. All the aforementioned measures will be collected during two weeks (sleep quality, athletic performance during training).
After analysis of the results further testing will be recommended as needed as well as changes in training programs, daily scheduling and sleep schedules.
During the entire study there will be close monitoring of injuries among participants. Events will be defined as injuries (according to the number of treatments by a physiotherapist or visits to a doctor) or near injuries and will be quantified, and correlations will be sought between performance, injuries and sleep duration.
In both stages in addition to wearing a heart rate belt, the participants will be asked to fill out a questionnaire before and after sleep during the entire study (see attached document).
Note: Suunto is a Finnish company that makes advanced sports watches and sensitive heart rate belts used by athletes in their training. The belt is soft, of very high quality, lightweight and contains a sensor and memory unit to store the heart rate data of the participant. It is approved for routine use for monitoring heart rate in people engaged in physical activity.
Expected benefits:
- Better understanding of the physiology associated with sleep among adolescents involved in regular, competitive physical activity.
- Improved performance by building a sleep program, optimal wakefulness and training.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 13-20 years old, male and female
- Generally good health
- Willingness to participate in the study
- Healthy heart rate
Key exclusion criteria (3 listed)
- Arrhythmia
- Chronic or acute illness
- Unwillingness of the subject or his/her parents to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep extensionAthletic performance evaluated at baseline and following about 1.5 hours of sleep extension | Behavioural | – |
Primary outcome
Improved athletic performance: reduced swimming and running times over predefined distances with sleep extension
Time frame: 12 months
Measure the changes in performance (running and swimmimng time) as follows: for runners- time required for 3000 m distance. for swimmers- time required for 50 m, 100 m, and 400 m, at predefined heart rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
- Related InfoLink provided by the sponsor.
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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.
Eyal Shargal, PhD principal investigator
Wingate Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension in people with Quality Sleep Time and Athletic Performance, run by Wingate Institute at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 1 Jan 2014. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved athletic performance: reduced swimming and running times over predefined distances with sleep extension (time frame: 12 months). 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 1 Jan 2014.