SleepSleep ProfilerNCT03773601
Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.
A study testing Sleep Profiler, PSQI and TQR in people with Sleep and Athlete, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Sleep is a crucial factor for athletes' health and recovery. Many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Athlete, Sleep Deprivation
- What is being tested?
- Sleep Profiler, PSQI and TQR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2018to 11 Nov 2020
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both genders
- age between 18 and 45
- sport activity for > or = to 8 hours/week.
- signed informed consent
Who cannot join
- smoking
- part-time or shift worker.
- Use of medications able to influence sleep
- any medical conditions (injury) contraindicating physical exercise as diagnosed by a sports medicine physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective Sleep Behavior in Relation to a Nigth Competition in Athletes: a Pilot Study.
Sleep is a crucial factor for athletes' health and recovery. Many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. Therefore, the aim of this pilot study is to evalute how sleep quality changes in relation to a late nigth competition in athletes.
- Conditions
- Sleep, Athlete, Sleep Deprivation
- Being tested
- Sleep Profiler, PSQI, TQR
- Keywords
- Sleep, Athlete, Sleep Profiler
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ProfilerOther
A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
PSQIOther
Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
TQROther
Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Experimental | Athletes will undergo a 4-days sleep monitoring with the use of the Sleep Profler. At the same time, they will fill the Total Quality of Recovery (TQR) scale and the Pittsburgh Sleep Quality Index (PSQI). Receives: Other: Sleep Profiler; Other: PSQI; Other: TQR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Evaluation of the changes in Sleep Efficiency, evaluated by the Sleep Profiler, before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.
Measured: From the 1st to the 4th nigth of monitoring
Secondary outcomes (1)
TQR
Evaluation of the changes in the subjective perception of recovery, evaluated with the Total Quality of Recovery Scale (TQR), before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.
Measured: From the 1st to the 4th nigth of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start16 Oct 2018
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773601
- Sponsor's protocol ID
- Sleep Profiler and athletes
- Acronym
- Sleep Profiler
- Status last verified
- Nov 2020
- First submitted
- 11 Dec 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Sleep Behavior in Relation to a Nigth Competition in Athletes: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03773601
- Acronym / sponsor ID
- Sleep Profiler / Sleep Profiler and athletes
- Conditions
- Sleep, Athlete, Sleep Deprivation
- Keywords
- Sleep, Athlete, Sleep Profiler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 12 Dec 2018 (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.
Sleep is a crucial factor for athletes' health and recovery. Many variables are able to negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high volume or high-intensity training period, and a nigth competition too. Therefore, the aim of this pilot study is to evalute how sleep quality changes in relation to a late nigth competition in athletes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes | Experimental | Other: Sleep Profiler, Other: PSQI, Other: TQRAthletes will undergo a 4-days sleep monitoring with the use of the Sleep Profler. At the same time, they will fill the Total Quality of Recovery (TQR) scale and the Pittsburgh Sleep Quality Index (PSQI). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- both genders
- age between 18 and 45
- sport activity for > or = to 8 hours/week.
- signed informed consent
Key exclusion criteria (4 listed)
- smoking
- part-time or shift worker.
- Use of medications able to influence sleep
- any medical conditions (injury) contraindicating physical exercise as diagnosed by a sports medicine physician
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 ProfilerA 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected. | Other | Athletes |
| PSQIFill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep. | Other | Athletes |
| TQRFill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery, | Other | Athletes |
Primary outcome
Sleep Efficiency
Time frame: From the 1st to the 4th nigth of monitoring
Evaluation of the changes in Sleep Efficiency, evaluated by the Sleep Profiler, before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.
1 secondary outcome
TQR
Time frame: From the 1st to the 4th nigth of monitoring
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 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
Not yet recruiting
The Sleep and Weight Study
Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Profiler, PSQI and TQR in people with Sleep and Athlete, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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: finished, as of the sponsor's last update on 13 Nov 2020. 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 Italy. 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?
Sleep Efficiency (time frame: From the 1st to the 4th nigth of monitoring). 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 13 Nov 2020.