NCT06944574

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

April 2, 2025

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 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 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

    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).

Study Arms (1)

Intervention Arm (one arm only, repeated measure design)

EXPERIMENTAL
Behavioral: Guided online intervention

Interventions

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.

Intervention Arm (one arm only, repeated measure design)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elite athlete participating in the recruit school (sport soldiers), understanding German because the content of the App is only available in German

You may not qualify if:

  • not understanding German good enough to understand the content of the App

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Federal Institute of Sport Magglingen

Magglingen, Canton of Bern, 2532, Switzerland

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 25, 2025

Study Start

November 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 25, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Small study sample with elite athletes, sharing data cannot garantee anonymity of participants

Locations