## Protocol Section
### Identification Module
**NCT ID:** NCT06418737

**Brief Title:** Sleep Hygiene Training in Gymnasts: Sleep Behaviour, Quality and Sleepiness

**Official Title:** Sleep Hygiene Training in Gymnasts: Quasi-Experimental Study on Sleep Behaviour, Quality and Sleepiness

#### Organization Study ID Info
**ID:** BAIBU-SBF-UK-01
#### Organization
**Class:** OTHER
**Full Name:** Abant Izzet Baysal University
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Abant Izzet Baysal University

#### Responsible Party

**Investigator Affiliation:** Abant Izzet Baysal University

**Investigator Full Name:** Ümid Karlı

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Sleep is essential to human health and well-being. Lack of or poor sleep can negatively impact cognitive function, mood, and physical performance. Athletes, especially elite athletes, are at risk for sleep problems due to heavy training schedules and the stress of travel.

Lack of or poor sleep can negatively impact athletes in many ways, including lack of sleep can lead to mood disorders such as irritability, anxiety, and depression. This may have a negative impact on athlete motivation and participation in training. Sleep deprivation can lead to decreased muscle strength, endurance, and coordination. This can affect an athlete's performance in training and competition phase.

Sleep hygiene refers to a set of practices aimed at regulating the sleep environment and habits to improve sleep quality. Sleep hygiene education is an intervention designed to teach athletes about the importance of sleep hygiene to improve their sleep quality. As sleep quality improves, attention, concentration, memory, and decision-making skills also improve . This can help athletes to perform better during training and competition. As sleep quality improves, mood disorders such as irritability, anxiety, and depression decrease. This can increase athlete motivation and participation in training. As sleep quality improves, so does muscle strength, endurance, and coordination.

**Detailed Description:** This study will be one of the first study conduct on human to examine the effectiveness of sleep hygiene education among gymnasts. Gymnasts, like other athletes, are prone to sleep problems for the reasons mentioned above. Therefore, it is of great significance to study the impact of sleep hygiene education on the sleep quality of gymnasts and indirectly on sports performance and sleep health as well as its underlying mechanisms. Additionally, this study has the potential to make a significant contribution to the field of exercise science by examining the effectiveness of sleep hygiene education, specifically among gymnasts. By examining effects on sleep quality, athletic performance, and sleep health, this study could provide valuable insights into developing targeted interventions to optimize sleep and health in gymnasts.

The duration of the measurements will be in week 1 to see the acute effects of sleep, and as a minimum of 18-21 days is required for behavioural change, sleep measurements will be made in week 4.

### Conditions Module

**Conditions:**

- Sleep Hygiene

- Habit, Good Sleep

**Keywords:**

- Sleep Quality

- Sleep Hygiene

- Sleep Habits

- Athletes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Single masked, randomized trial (experimental and control group)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participants are masked

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sleep Intervention: A 60-minute sleep hygiene education session will be delivered to the participants by an expert with experience in providing education in the areas of sports and sleep. Subsequently, interventions will be implemented to improve the sleep environments of the athletes who are staying at the facility

**Intervention Names:**

- Behavioral: Sleep HygieneTraining

**Label:** Sleep Training Group:

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No training will be provided If offered by the control group participants, "sleep hygiene training" will be given after all the data collected from the Sleep Training Group

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sleep Training Group:

**Description:** Training Content

* Importance of Sleep: The vital importance of sleep for physical and mental health.
* Benefits of Adequate and Quality Sleep: The numerous benefits of sufficient and good quality sleep.
* Sleep Stages: The different stages of sleep and their characteristics.
* Sleep Hygiene: The concept of sleep hygiene and its importance for improving sleep quality.
* What to Do?
* What to Avoid for Better Sleep?

**Name:** Sleep HygieneTraining

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography

**Measure:** Actigraphy

**Time Frame:** Pre-test, following one week mid-test and following one month post-test

**Description:** Athlete Sleep Behavior Questionnaire is a 17-item, Likert-type (1- Never, 5- Always) scale with 4 sub-factors (sports-related, sleep quality, habitual sleep efficiency, sleep disturbance)

**Measure:** Athlete Sleep Behavior Questionnaire (ASBQ)

**Time Frame:** Pre-test and 1 month after the pre-test

**Description:** Pittsburgh Sleep Quality Index assesses various sleep-related factors, including sleep latency, sleep duration, sleep efficiency, and daytime sleepiness.

It is a 19-item self-report questionnaire. Each item is scored from 0 to 3, and the total score ranges from 0 to 57. Higher scores indicate poorer sleep quality.

**Measure:** Pittsburgh Sleep Quality Index (PSQI)

**Time Frame:** Pre-test and 1 month after the pre-test

**Description:** Cleveland Adolescent Sleepiness Questionnaire provides a valid and reliable subjective measure of daytime sleepiness in adolescents.

This Questionnaire consists of 16 items that measure daytime sleepiness. Scores range from 16 to 80 on a 5-point Likert scale (never: 1; rarely: 2; sometimes: 3; usually: 4; almost every day: 5). Five of the statements are scored in the reverse direction. Daytime sleepiness is obtained by summing the scores of the 16 items, and the higher the score, the higher the daytime sleepiness.

**Measure:** Cleveland Adolescent Sleepiness Questionnaire

**Time Frame:** Pre-test and 1 month after the pre-test

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Voluntariness: Participants must be willing to participate in the study voluntarily and provide informed consent.
* Elite Gymnasts: Participants must be elite gymnasts competing at the national level.
* Being Healthy: Participants must be in good health and free of any significant medical conditions that could affect their sleep or participation in the study.
* No Prior Sleep Hygiene Training: Participants must not have received any formal sleep education or intervention in the past.

Exclusion Criteria:

* Complications During the Intervention: Participants who experience any complications during the sleep hygiene education intervention will be excluded from the study.
* Regular Use of Sleep-Affecting Medication

**Gender Based:** True

**Gender Description:** Male individuals will be included due to the fact that women's hormonal responses may cause heterogeneous findings and the difficulty in interpreting the findings due to their hormonal profile.

**Healthy Volunteers:** True

**Maximum Age:** 20 Years

**Minimum Age:** 15 Years

**Sex:** MALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** karli_u@ibu.edu.tr

**Name:** Umid Karli, PhD

**Phone:** +90 374 254 10 00

**Phone Ext:** 7501

**Role:** CONTACT

**Contact 2:**

**Email:** aydin_k@ibu.edu.tr

**Name:** Kutlu Aydın, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bolu

**Contacts:**

***Contact 1:***

- **Email:** karli_u@ibu.edu.tr

- **Name:** Umid Karli, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Umid Karli, Phd

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Semih Karaman, Ms

- **Role:** SUB_INVESTIGATOR

**Country:** Turkey

**Facility:** Bolu Abant İzzet Baysal University, Faculty of Sport Sciences,

**Status:** RECRUITING

**Zip:** 14030

#### Overall Officials

**Official 1:**

**Affiliation:** Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education

**Name:** Umid Karli, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1717

- Name: Sleepiness

- Relevance: HIGH

- As Found: Sleepiness

### Condition Browse Module - Meshes

- ID: D000077260

- Term: Sleepiness

### Misc Info Module

- Version Holder: 2024-05-31
