Sleep ProblemsSISEANCT06944574
Sleep Intervention Swiss Elite Athletes
A study testing Guided online intervention in people with Sleep Problems, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
Trial summary
Background and Rationale Elite athletes frequently experience sleep disturbances due to factors like irregular schedules, travel, and pre-competition stress. Despite the critical role of sleep in physical recovery and mental health, many athletes fail to meet sleep quality recommendations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems
- What is being tested?
- Guided online intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 31 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elite athlete participating in the recruit school (sport soldiers), understanding German because the content of the App is only available in German
Who cannot join
- not understanding German good enough to understand the content of the App
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Federal Institute of Sport Magglingen
Magglingen, Canton of Bern, 2532
About this study
Background and Rationale Elite athletes frequently experience sleep disturbances due to factors like irregular schedules, travel, and pre-competition stress. Despite the critical role of sleep in physical recovery and mental health, many athletes fail to meet sleep quality recommendations. While sleep interventions have shown promise in improving sleep outcomes, their effects on mental health-especially in athlete populations-remain underexplored. This study investigates the impact of a 4-week app-based sleep intervention, preceded by a workshop, on both sleep and mental health outcomes in Swiss elite athletes.
Objective To evaluate whether a brief, structured sleep intervention improves sleep quality and mental health in elite athletes and to identify perceived facilitators and barriers to intervention success.
Read more
Design A single-center, one-arm pre-post intervention study with four time points (baseline, pre-intervention, post-intervention, and 2-month follow-up). No control group is used due to practical constraints.
Participants 16 elite athletes (sport soldiers) enrolled in the Swiss recruit school. All participants are adults and proficient in German.
Intervention
A one-hour sleep workshop covering the importance of sleep and motivation-setting.
A four-week app-based program ("7-Schläfer") with seven audio modules (approx. 30 minutes each), completed flexibly by participants.
Outcomes
Primary outcomes include:
Sleep quality and disturbances
Mental health (depression, anxiety, well-being)
Data will be collected via REDCap using validated questionnaires. After the intervention, individual interviews will gather qualitative feedback.
Analysis Quantitative data will be analyzed using repeated measures ANOVA. Focus group data will be analyzed thematically.
Significance The study aims to provide practical, scalable insights into how sleep-focused interventions can improve athlete well-being and inform recommendations for sport organizations.
Read the detailed description
- Background and Rationale Elite athletes often suffer from sleep disturbances due to high training loads, frequent travel, jet lag, pre-competition stress, and irregular routines. Poor sleep negatively affects cognitive function, immune response, recovery, and overall performance. It is also strongly associated with mental health challenges including anxiety, depression, and psychological distress. Although interventions such as sleep hygiene education and sleep extension strategies show promise in improving subjective sleep quality, there is limited evidence on their long-term effectiveness or impact on mental health in elite athlete populations. Moreover, few studies examine what elements of sleep interventions athletes perceive as most helpful or what barriers they face. This study seeks to close these gaps by evaluating the short- and long-term effects of a structured sleep intervention on sleep quality and mental health in elite Swiss athletes, with additional qualitative data on user experience.
- Study Objectives Primary Objective To determine whether a 4-week sleep intervention improves sleep quality and mental health (depression, anxiety, and well-being) in elite athletes. Hypotheses The intervention will reduce sleep disturbances and improve sleep quality. The intervention will enhance mental health outcomes, including reduced symptoms of depression and anxiety and improved well-being. Secondary Objectives To explore participant experiences, including perceived facilitators, barriers, and the most helpful components of the intervention.
- Study Design This is a national, single-center, one-arm pre-post intervention study using a within-subjects design. It includes four measurement time points: T0: Baseline T1: Pre-intervention T2: Post-intervention T3: Two-month follow-up
- Participants Sample Size: 16 elite athletes from the recruit school (sport soldiers). Inclusion Criteria: Enrolled in the recruit school Elite athlete status Sufficient understanding of German Exclusion Criteria: Insufficient German to engage with the app All participants are adults capable of providing informed consent.
- Intervention Component 1: Workshop A one-hour in-person workshop focused on the importance of sleep for physical and mental performance, sleep hygiene strategies, and goal setting. Participants identify personal motivations, which are later used to encourage adherence. Component 2: App-Based Sleep Program ("7-Schläfer") Participants complete 7 modules (approx. 30 minutes each) over four weeks. Modules include guided audio exercises and psychoeducation about sleep. Participants can take private notes, which are not accessed by the research team. Weekly reminder emails with personalized motivational cues are sent to enhance engagement. Participation in the intervention is free of charge. The app is provided at no cost and without data sharing.
- Outcomes and Measurements Validated questionnaires will be used: Sleep Quality: Visual analog scale (1 item) Sleep Disturbance: Insomnia Severity Index (ISI, 7 items) Well-Being: MHC-SF (14 items) Depression: PHQ-9 (9 items) Anxiety: GAD-7 (7 items) Participants also report demographic data, sport type, training intensity, and adherence (module completion and perceived usefulness). Post-intervention, optional focus groups (2 groups of 6-9 athletes) explore facilitators, barriers, and perceived effectiveness.
- Data Collection and Management All data is collected through REDCap. Only three project staff members have access. Identifying data is stored separately and pseudonymized.
- Statistical Analysis Repeated measures ANOVA will assess within-subject changes across the four time points. Power analysis determined that 24 participants are needed for moderate effect detection. To account for attrition, 30 athletes will be recruited. Qualitative data from focus groups will be analyzed using thematic analysis. Gender will be included as a control variable. Missing data will be handled using multiple imputation. Participants must complete at least baseline and post-intervention assessments to be included in analysis.
- Ethics and Risk Assessment The study is categorized as minimal risk (ClinO, Art. 61, Cat. A). No vulnerable populations are included. Ethical risks are low and primarily involve potential distress when reflecting on sleep habits. Participants are provided with mental health resources and may contact the research team or sport psychology services at any time.
- Monitoring and Safety A trained monitor from the Swiss Federal Institute of Sport will conduct site visits at initiation, mid-study, and study close-out. Serious Adverse Events will be reported per ClinO requirements. No radiation, invasive procedures, or vulnerable groups are involved.
- Registration and Dissemination The study will be registered with SNCTP and ClinicalTrials.gov. Results will be published open access and anonymized data will be made publicly available after project completion.
- Funding Funded by the Swiss National Science Foundation (project number PT00P1_199093 / 1). There are no financial or personal conflicts of interest.
- Conditions
- Sleep Problems
- Being tested
- Guided online intervention
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided online interventionBehavioural
The intervention combines a one-hour in-person workshop with a four-week app-based program tailored to elite athletes. The workshop focuses on sleep education and individual motivation setting. Athletes then complete seven self-paced audio modules via the "7-Schläfer" app, covering strategies to improve sleep quality. Weekly reminder emails reinforce motivation. Unlike other interventions, this program is fully integrated into the elite sport context, emphasizes behavioral change through personalized goal-setting, and includes no therapist contact, ensuring scalability. No control group is included in this one-arm pre-post design.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (one arm only, repeated measure design) | Experimental | Not described Receives: Behavioral: Guided online intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep problems
The Insomnia Severity Index (ISI, Gerber et al., 2016) was used to assess the severity of sleep problems. The ISI consists of seven items, evaluating difficulties with falling asleep, staying asleep, subjective sleep quality, the impact of sleep disturbances on daily life, and worries about sleep problems in the previous two weeks. Participants rated each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). A total sleep problem score was calculated by summing all item responses. Higher values indicate more sleep problems.
Measured: The ISI was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Secondary outcomes (3)
Depression
The 9-item Patient Health Questionnaire (PHQ-9, Kroenke et al., 2001) was used to assess depressive symptoms in the two preceding weeks. The PHQ-9 asks participants to self-assess nine problems (e.g., "I had little interest or pleasure in doing things") on a 4-point scale ranging from not at all (0) to nearly every day (3). A total depression score was obtained by summing all item responses. Higher scores indicate more depressive symptoms.
Measured: The PHQ-9 was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Anxiety
The 7-item General Anxiety Disorder (GAD-7, Spitzer et al., 2006; Spitzer et al., 1999) was used to assess anxiety symptoms in the two preceding weeks. The GAD-7 asks participants to self-assess seven core symptoms of generalized anxiety disorder (e.g., "I had not been able to stop or control worrying") on a 4-point scale ranging from not at all (0) to nearly every day (3). A total anxiety score was obtained by summing all item responses. Higher scores indicate more anxiety symptoms.
Measured: The GAD-7 was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Well-being
To assess well-being, we used the 14-item Mental Health Continuum Short Form (MHC-SF, Lamers et al., 2011). The MHC-SF comprises three subscales: emotional well-being (three items; e.g., "During the past month, how often did you feel satisfied with life?"); social well-being (five items; e.g., "During the past month, how often did you feel that you had something important to contribute to society?"); and psychological well-being (six items; e.g., "During the past month, how often did you feel that you had experiences that challenged you to grow and become a better person?"). Items are rated on a 6-point scale ranging from never (1) to every day (6), and mean scores are calculated for the three subscales and the total scale. Higher score indicate greater well-being.
Measured: The MHC-SF was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Sport Magglingen
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944574
- Sponsor's protocol ID
- 2024-02076
- Other IDs
- PT00P1_199093 / 1
- Acronym
- SISEA
- Status last verified
- Oct 2024
- First submitted
- 2 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small study sample with elite athletes, sharing data cannot garantee anonymity of participants
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Intervention Swiss Elite Athletes
- ClinicalTrials.gov ID
- NCT06944574
- Acronym / sponsor ID
- SISEA / 2024-02076
- Conditions
- Sleep Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Federal Institute of Sport MagglingenOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 25 Apr 2025 (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.
Background and Rationale Elite athletes frequently experience sleep disturbances due to factors like irregular schedules, travel, and pre-competition stress. Despite the critical role of sleep in physical recovery and mental health, many athletes fail to meet sleep quality recommendations. While sleep interventions have shown promise in improving sleep outcomes, their effects on mental health-especially in athlete populations-remain underexplored. This study investigates the impact of a 4-week app-based sleep intervention, preceded by a workshop, on both sleep and mental health outcomes in Swiss elite athletes.
Objective To evaluate whether a brief, structured sleep intervention improves sleep quality and mental health in elite athletes and to identify perceived facilitators and barriers to intervention success.
Design A single-center, one-arm pre-post intervention study with four time points (baseline, pre-intervention, post-intervention, and 2-month follow-up). No control group is used due to practical constraints.
Participants 16 elite athletes (sport soldiers) enrolled in the Swiss recruit school. All participants are adults and proficient in German.
Intervention
A one-hour sleep workshop covering the importance of sleep and motivation-setting.
A four-week app-based program ("7-Schläfer") with seven audio modules (approx. 30 minutes each), completed flexibly by participants.
Outcomes
Primary outcomes include:
Sleep quality and disturbances
Mental health (depression, anxiety, well-being)
Data will be collected via REDCap using validated questionnaires. After the intervention, individual interviews will gather qualitative feedback.
Analysis Quantitative data will be analyzed using repeated measures ANOVA. Focus group data will be analyzed thematically.
Significance The study aims to provide practical, scalable insights into how sleep-focused interventions can improve athlete well-being and inform recommendations for sport organizations.
Detailed description
- Background and Rationale Elite athletes often suffer from sleep disturbances due to high training loads, frequent travel, jet lag, pre-competition stress, and irregular routines. Poor sleep negatively affects cognitive function, immune response, recovery, and overall performance. It is also strongly associated with mental health challenges including anxiety, depression, and psychological distress. Although interventions such as sleep hygiene education and sleep extension strategies show promise in improving subjective sleep quality, there is limited evidence on their long-term effectiveness or impact on mental health in elite athlete populations. Moreover, few studies examine what elements of sleep interventions athletes perceive as most helpful or what barriers they face. This study seeks to close these gaps by evaluating the short- and long-term effects of a structured sleep intervention on sleep quality and mental health in elite Swiss athletes, with additional qualitative data on user experience.
- Study Objectives Primary Objective To determine whether a 4-week sleep intervention improves sleep quality and mental health (depression, anxiety, and well-being) in elite athletes. Hypotheses The intervention will reduce sleep disturbances and improve sleep quality. The intervention will enhance mental health outcomes, including reduced symptoms of depression and anxiety and improved well-being. Secondary Objectives To explore participant experiences, including perceived facilitators, barriers, and the most helpful components of the intervention.
- Study Design This is a national, single-center, one-arm pre-post intervention study using a within-subjects design. It includes four measurement time points: T0: Baseline T1: Pre-intervention T2: Post-intervention T3: Two-month follow-up
- Participants Sample Size: 16 elite athletes from the recruit school (sport soldiers). Inclusion Criteria: Enrolled in the recruit school Elite athlete status Sufficient understanding of German Exclusion Criteria: Insufficient German to engage with the app All participants are adults capable of providing informed consent.
- Intervention Component 1: Workshop A one-hour in-person workshop focused on the importance of sleep for physical and mental performance, sleep hygiene strategies, and goal setting. Participants identify personal motivations, which are later used to encourage adherence. Component 2: App-Based Sleep Program ("7-Schläfer") Participants complete 7 modules (approx. 30 minutes each) over four weeks. Modules include guided audio exercises and psychoeducation about sleep. Participants can take private notes, which are not accessed by the research team. Weekly reminder emails with personalized motivational cues are sent to enhance engagement. Participation in the intervention is free of charge. The app is provided at no cost and without data sharing.
- Outcomes and Measurements Validated questionnaires will be used: Sleep Quality: Visual analog scale (1 item) Sleep Disturbance: Insomnia Severity Index (ISI, 7 items) Well-Being: MHC-SF (14 items) Depression: PHQ-9 (9 items) Anxiety: GAD-7 (7 items) Participants also report demographic data, sport type, training intensity, and adherence (module completion and perceived usefulness). Post-intervention, optional focus groups (2 groups of 6-9 athletes) explore facilitators, barriers, and perceived effectiveness.
- Data Collection and Management All data is collected through REDCap. Only three project staff members have access. Identifying data is stored separately and pseudonymized.
- Statistical Analysis Repeated measures ANOVA will assess within-subject changes across the four time points. Power analysis determined that 24 participants are needed for moderate effect detection. To account for attrition, 30 athletes will be recruited. Qualitative data from focus groups will be analyzed using thematic analysis. Gender will be included as a control variable. Missing data will be handled using multiple imputation. Participants must complete at least baseline and post-intervention assessments to be included in analysis.
- Ethics and Risk Assessment The study is categorized as minimal risk (ClinO, Art. 61, Cat. A). No vulnerable populations are included. Ethical risks are low and primarily involve potential distress when reflecting on sleep habits. Participants are provided with mental health resources and may contact the research team or sport psychology services at any time.
- Monitoring and Safety A trained monitor from the Swiss Federal Institute of Sport will conduct site visits at initiation, mid-study, and study close-out. Serious Adverse Events will be reported per ClinO requirements. No radiation, invasive procedures, or vulnerable groups are involved.
- Registration and Dissemination The study will be registered with SNCTP and ClinicalTrials.gov. Results will be published open access and anonymized data will be made publicly available after project completion.
- Funding Funded by the Swiss National Science Foundation (project number PT00P1_199093 / 1). There are no financial or personal conflicts of interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (one arm only, repeated measure design) | Experimental | Behavioral: Guided online intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elite athlete participating in the recruit school (sport soldiers), understanding German because the content of the App is only available in German
Key exclusion criteria (1 listed)
- not understanding German good enough to understand the content of the App
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 |
|---|---|---|
| Guided online interventionThe intervention combines a one-hour in-person workshop with a four-week app-based program tailored to elite athletes. The workshop focuses on sleep education and individual motivation setting. Athletes then complete seven self-paced audio modules via the "7-Schläfer" app, covering strategies to improve sleep quality. Weekly reminder emails reinforce motivation. Unlike other interventions, this program is fully integrated into the elite sport context, emphasizes behavioral change through personalized goal-setting, and includes no therapist contact, ensuring scalability. No control group is included in this one-arm pre-post design. | Behavioural | Intervention Arm (one arm only, repeated measure design) |
Primary outcome
Sleep problems
Time frame: The ISI was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
The Insomnia Severity Index (ISI, Gerber et al., 2016) was used to assess the severity of sleep problems. The ISI consists of seven items, evaluating difficulties with falling asleep, staying asleep, subjective sleep quality, the impact of sleep disturbances on daily life, and worries about sleep problems in the previous two weeks. Participants rated each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). A total sleep problem score was calculated by summing all item responses. Higher values indicate more sleep problems.
3 secondary outcomes
Depression
Time frame: The PHQ-9 was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Anxiety
Time frame: The GAD-7 was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
Well-being
Time frame: The MHC-SF was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).
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 25 Apr 2025.
- Individual participant dataSharing planned: No. Small study sample with elite athletes, sharing data cannot garantee anonymity of participants
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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 Guided online intervention in people with Sleep Problems, run by Swiss Federal Institute of Sport Magglingen at 1 site in Switzerland.
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 1 inclusion and 1 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 25 Apr 2025. 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 Switzerland. 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 problems (time frame: The ISI was administered at four time points: (1) baseline, (2) pre-intervention (4 weeks later, immediately before intervention), (3) post-intervention (6 weeks after pre-intervention), and (4) follow-up (2 months after post-intervention).). 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 25 Apr 2025.