SleepSleep&SurgeonNCT06213246
Sleep and Performance in Surgeons
A study testing Sleep Hygiene Strategies in people with Sleep, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The primary aim of this study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. Read more about this study
- Who is it for?
- Ages 23 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Hygiene Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2023to 31 Dec 2025
- 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 23 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, of any ethnicity;
- Age between 23 and 70 years old;
- Cognitively intact;
- Orthopedic surgeons or medical residents specializing in Orthopedics.
- Signature and acceptance of informed consent to collaborate in all procedures necessary for the study.
Who cannot join
- Individuals younger than 23 years old or older than 70 years old;
- Any clinical condition that prevents the subject from participating in operating room activities (e.g., muscle injury, COVID-19 positivity, feverish or flu-like states, etc.).
- Non-participation, for any reason, in surgical activities in daily clinical practice.
- Clinically diagnosed sleep disorders.
- Women who have been pregnant or breastfeeding within 12 months before signing the informed consent or during the recruitment and observation period. [self-declaration]
- Non-acceptance of the informed consent.
- Physical impossibility to undergo the evaluations required by the study using the devices specified in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Surgery and Sleep Hygiene Strategies on Strength, Sleep Parameters, and Cognitive Performance in Orthopedic Surgeons
The primary aim of this study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes in actigraphic sleep parameters, salivary cortisol levels, cognitive performance, and subjective perception levels of effort and drowsiness.
Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (week 2 vs week 3).
Read the detailed description
Currently, there are few scientific studies that have assessed the relationship between sleep quality, strength expression, and cognitive performance among orthopedic surgeons. Furthermore, no previous study has ever evaluated the effect of a behavioral sleep hygiene strategy on actigraphic sleep parameters in orthopedic surgeons.
Therefore, the primary aim of the study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes on lower limbs strength (maximal isometric strength of extensors of knee by digital dynamometer), salivary cortisol levels, cognitive performance (Stroop test and Bomb Risk Elicitation Task), and subjective perception levels of effort and drowsiness (Borg CR-10 and Karolinska Sleepiness Scale).
Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (control week vs Sleep hygiene strategies week).
The study involves 3 weeks of assessment (Week 1, 2, and 3), not necessarily consecutive.
Assessments within Week 1:
- Sleep monitoring using actigraphy and a sleep diary for the entire week, along with completing the Morningness-Eveningness Questionnaire and Pittsburgh Sleep Quality Index.
Assessments within Week 2 and Week 3:
- Sleep monitoring using actigraphy and a sleep diary for the entire week.
- Pre and post-surgical operation evaluations:
- Measurement of strength using dynamometers.
- Cognitive assessment using Stroop test and Bomb Risk Elicitation Task.
- Evaluation of salivary cortisol levels using "Salivette".
- Assessment of perceived exertion using the Borg CR10 scale.
- Evaluation of drowsiness levels using the Karolinska Sleepiness Scale.
Note: In Week 3, sleep hygiene strategies will be implemented.
- Conditions
- Sleep
- Being tested
- Sleep Hygiene Strategies
- Keywords
- surgery, sleep, surgeon, strength, cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene StrategiesBehavioural
The sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the following guidelines recommended by the National Sleep Foundation
- Maintain a consistent wake-up and bedtime schedule during workdays.
- Do not delay/advance excessively (no more than 2 hours) the wake-up and bedtime - schedule during weekends.
- Keep the bedroom temperature below 22°C.
- Avoid sources of light and noise in the bedroom.
- Use the bed only for sleeping, avoiding other activities before bedtime.
- Avoid daytime naps during workdays.
- Refrain from using electronic devices (PC, laptop, cellphone, television) at least 30 minutes before bedtime.
- Expose yourself to natural light in the morning and reduce artificial lights in the evening.
- Avoid consuming alcoholic beverages and caffeine in the afternoon.
- Have a moderately sized dinner at least 3 hours before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Strategies (SHS) | Experimental | In Week 3, the study participants will implement sleep hygiene strategies. Specifically, these sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the guidelines recommended by the National Sleep Foundation. Receives: Behavioral: Sleep Hygiene Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Test
Handgrip is a measure of the maximal isometric force that a hand can squeeze, and it is widely used because very easy and inexpensive. The handgrip strength is performed three-times for each hand alternatively, starting with the dominant hand, using a digital dynamometer to the nearest 0.1kg. Participants perform the test in a sitting position with the shoulder adducted, elbow flexed at 90-degree angle, forearm in neutral position. Participants rest 30 seconds among each repetition. The peak of the three repetitions is calculated and use for statistical analysis.
Measured: The handgrip test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 4 minutes to complete. The test is performed both before and after the surgery.
Secondary outcomes (9)
Lower limbs isometric strength
Maximal isometric strength of extensors of knee is measured, for both lower limbs alternatively, using a digital dynamometer with subjects in a sitting position and the knee placed at 90° flexion. A resting period of 30-seconds is given after each repetition. The peak of the three repetitions is calculated and used for statistical analysis.
Measured: The maximal isometric strength test of extensors of knee is conducted on the seventh day of both Week 2 and Week 3, taking approximately 5 minutes to complete. The test is performed both before and after the surgery.
Sleep monitoring
Sleep parameters are objectively monitored by actigraphy. Also, participants complete a validated daily sleep diary to record bedtime, wake-up time, the number and duration of nocturnal awakenings, daytime napping, and subjective sleep quality. Data derive both from the sleep device and sleep diaries are used to determine the quantity and quality of sleep that participants obtain (Total sleep time; Sleep efficiency; Immobility time; Moving time; Fragmentation index; Wake after sleep onset; Subjective quality of sleep; Subjective sleepiness; Subjective tiredness). Sleep is monitored for seven consecutive days for each timepoint period (week 1, week 2 and week 3).
Measured: Seven days for each timepoint period (week 1, week 2 and week 3. 21 days in total)
Stroop Test
The Stroop test is a psychological assessment that evaluates cognitive processing speed and selective attention. The Stroop test involves presenting words in different colors and asking participants to name the color of the ink used to print the word.
Measured: The Stroop test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.
Bomb Risk Elicitation Task
The Bomb Risk Elicitation Task is a behavioral experiment designed to measure risk preferences under uncertainty. The task involves decision-making in a context where participants face varying levels of risk and potential gains or losses.
Measured: The Bomb Risk Elicitation Task is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.
Salivary cortisol
Assessment of salivary cortisol levels using Salivette tubes (Sarsted, Germany)
Measured: The assessment of salivary cortisol using "Salivette" is conducted on the seventh day of both Week 2 and Week 3, taking approximately 3 minutes to complete. The assessment is performed both before and after the surgery.
Borg CR-10
Borg CR-10 is a tool used to measure subjective perception of exertion during physical activity. This scale assesses an individual's subjective perception of effort or exertion during exercise, ranging from 0 (no exertion at all) to 10 (maximal exertion).
Measured: The Borg CR-10 evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
Karolinska Sleepiness Scale
The Karolinska Sleepiness Scale is a subjective self-assessment tool used to measure a person's level of sleepiness or alertness at a particular moment in time. This scale helps individuals rate their perceived sleepiness on a scale from 1 (Very alert) to 9 (Extremely sleepy, can't stay awake).
Measured: The Karolinska Sleepiness Scale evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a widely used self-report questionnaire that assesses an individual's sleep quality over a one-month time interval. It evaluates various aspects of sleep, including duration, latency, habitual sleep efficiency, disturbances, use of sleep medications, and daytime dysfunction. The global score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Measured: The Pittsburgh Sleep Quality Index evaluation is conducted at the end of Week 1, and taking approximately 4 minute to complete.
Morningness-Eveningness Questionnaire
The Morningness-Eveningness Questionnaire (MEQ) is a self-report questionnaire designed to assess an individual's chronotype, which refers to their preference for being active and alert during certain parts of the day. Based on the responses, individuals are scored on a scale (range from 16 to 86) that categorizes them into different chronotypes:
- Morning types (score: 59-86)
- Intermediate types (score: 42-58)
- Evening types (score: 16-41)
Measured: The Morningness-Eveningness Questionnaire is conducted at the end of Week 1, and taking approximately 4 minute to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start23 Oct 2023
- Primary completion23 Dec 2024
- Study completion31 Dec 2025
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is monocentric, prospective, and observational.
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT06213246
- Sponsor's protocol ID
- Sleep&Surgeons (L4157)
- Acronym
- Sleep&Surgeon
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgery and Sleep Hygiene Strategies on Strength, Sleep Parameters, and Cognitive Performance in Orthopedic Surgeons
- ClinicalTrials.gov ID
- NCT06213246
- Acronym / sponsor ID
- Sleep&Surgeon / Sleep&Surgeons (L4157)
- Conditions
- Sleep
- Keywords
- surgery, sleep, surgeon, strength, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Jan 2024 (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.
The primary aim of this study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes in actigraphic sleep parameters, salivary cortisol levels, cognitive performance, and subjective perception levels of effort and drowsiness.
Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (week 2 vs week 3).
Detailed description
Currently, there are few scientific studies that have assessed the relationship between sleep quality, strength expression, and cognitive performance among orthopedic surgeons. Furthermore, no previous study has ever evaluated the effect of a behavioral sleep hygiene strategy on actigraphic sleep parameters in orthopedic surgeons.
Therefore, the primary aim of the study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes on lower limbs strength (maximal isometric strength of extensors of knee by digital dynamometer), salivary cortisol levels, cognitive performance (Stroop test and Bomb Risk Elicitation Task), and subjective perception levels of effort and drowsiness (Borg CR-10 and Karolinska Sleepiness Scale).
Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (control week vs Sleep hygiene strategies week).
The study involves 3 weeks of assessment (Week 1, 2, and 3), not necessarily consecutive.
Assessments within Week 1:
- Sleep monitoring using actigraphy and a sleep diary for the entire week, along with completing the Morningness-Eveningness Questionnaire and Pittsburgh Sleep Quality Index.
Assessments within Week 2 and Week 3:
- Sleep monitoring using actigraphy and a sleep diary for the entire week.
- Pre and post-surgical operation evaluations:
- Measurement of strength using dynamometers.
- Cognitive assessment using Stroop test and Bomb Risk Elicitation Task.
- Evaluation of salivary cortisol levels using "Salivette".
- Assessment of perceived exertion using the Borg CR10 scale.
- Evaluation of drowsiness levels using the Karolinska Sleepiness Scale.
Note: In Week 3, sleep hygiene strategies will be implemented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is monocentric, prospective, and observational.
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Strategies (SHS) | Experimental | Behavioral: Sleep Hygiene StrategiesIn Week 3, the study participants will implement sleep hygiene strategies. Specifically, these sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the guidelines recommended by the National Sleep Foundation. |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, of any ethnicity;
- Age between 23 and 70 years old;
- Cognitively intact;
- Orthopedic surgeons or medical residents specializing in Orthopedics.
- Signature and acceptance of informed consent to collaborate in all procedures necessary for the study.
Key exclusion criteria (7 listed)
- Individuals younger than 23 years old or older than 70 years old;
- Any clinical condition that prevents the subject from participating in operating room activities (e.g., muscle injury, COVID-19 positivity, feverish or flu-like states, etc.).
- Non-participation, for any reason, in surgical activities in daily clinical practice.
- Clinically diagnosed sleep disorders.
- Women who have been pregnant or breastfeeding within 12 months before signing the informed consent or during the recruitment and observation period. [self-declaration]
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 Hygiene StrategiesThe sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the following guidelines recommended by the National Sleep Foundation * Maintain a consistent wake-up and bedtime schedule during workdays. * Do not delay/advance excessively (no more than 2 hours) the wake-up and bedtime - schedule during weekends. * Keep the bedroom temperature below 22°C. * Avoid sources of light and noise in the bedroom. * Use the bed only for sleeping, avoiding other activities before bedtime. * Avoid daytime naps during workdays. * Refrain from using electronic devices (PC, laptop, cellphone, television) at least 30 minutes before bedtime. * Expose yourself to natural light in the morning and reduce artificial lights in the evening. * Avoid consuming alcoholic beverages and caffeine in the afternoon. * Have a moderately sized dinner at least 3 hours before bedtime. | Behavioural | Sleep Hygiene Strategies (SHS) |
Primary outcome
Handgrip Test
Time frame: The handgrip test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 4 minutes to complete. The test is performed both before and after the surgery.
Handgrip is a measure of the maximal isometric force that a hand can squeeze, and it is widely used because very easy and inexpensive. The handgrip strength is performed three-times for each hand alternatively, starting with the dominant hand, using a digital dynamometer to the nearest 0.1kg. Participants perform the test in a sitting position with the shoulder adducted, elbow flexed at 90-degree angle, forearm in neutral position. Participants rest 30 seconds among each repetition. The peak of the three repetitions is calculated and use for statistical analysis.
9 secondary outcomes
Lower limbs isometric strength
Time frame: The maximal isometric strength test of extensors of knee is conducted on the seventh day of both Week 2 and Week 3, taking approximately 5 minutes to complete. The test is performed both before and after the surgery.
Sleep monitoring
Time frame: Seven days for each timepoint period (week 1, week 2 and week 3. 21 days in total)
Stroop Test
Time frame: The Stroop test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.
Bomb Risk Elicitation Task
Time frame: The Bomb Risk Elicitation Task is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.
Salivary cortisol
Time frame: The assessment of salivary cortisol using "Salivette" is conducted on the seventh day of both Week 2 and Week 3, taking approximately 3 minutes to complete. The assessment is performed both before and after the surgery.
Borg CR-10
Time frame: The Borg CR-10 evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
Karolinska Sleepiness Scale
Time frame: The Karolinska Sleepiness Scale evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
Pittsburgh Sleep Quality Index
Time frame: The Pittsburgh Sleep Quality Index evaluation is conducted at the end of Week 1, and taking approximately 4 minute to complete.
Morningness-Eveningness Questionnaire
Time frame: The Morningness-Eveningness Questionnaire is conducted at the end of Week 1, and taking approximately 4 minute to complete.
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 24 Aug 2026.
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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.
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 Hygiene Strategies in people with Sleep, 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 5 inclusion and 7 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 24 Aug 2026. 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?
Handgrip Test (time frame: The handgrip test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 4 minutes to complete. The test is performed both before and after the surgery.). 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 24 Aug 2026.