tDCS in Improving Quality of Sleep in Athletes

Sleep Disorder Clinical Trial

— tDCS  

Official title:

The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318352
• Other study ID #: 80-2021
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University of Jordan
• Contact: Alia Alghwiri, PhD
• Phone: +96265355000
• Email: alia.alghwiri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep disturbances in athletes was found prevalent and affect their cognitive and physical abilities and increase the risk of injury. Moreover, studies showed also that a better sleep produces a better athletic performance. Therefore, it is important to find out management strategies that improve quality of sleep in this population.

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep. tDCS was used in improving the quality of sleep in older adults and in athletes. Both studies found improvement in some sleep indices.

Description:

Research ethics:

1. Institutional Review Board approval was sought out from University of Jordan before the beginning of the study.

2. Informed consent will be obtained from athletes guaranteed their approval to participate in the study.

3. To insure the privacy of participants, every athlete will be assigned a study identification number.

4. All results will be stored in a locked cabinet/computer.

Study design and participants:

This is double -blinded randomized placebo-controlled parallel trial. The study will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological treatment (Boutron et al., 2008). Data will be collected prospectively from athletes from different sports in Jordan.

Sample Size calculation:

The sample size was calculated using G*Power software, according to the study of Acler et al,. 2013. The study found Cohen d=0.7012 effect size of transcranial direct current stimulation on PSQI. Based on 0.7012 effect size, bidirectional alpha of 0.05, and 80% test power, a minimum of 70 participants were needed to the study. The sample will be increased by 20 % to compensate possible dropouts, overall sample of 84 participants will be included in this study.

Procedures:

1. Eligible athletes will be approached via the Jordanian Olympic Committee to participate in this study.

2. A researcher will explain the whole procedures of the research study including the randomization.

3. Athletes will go through baseline assessment.

4. A randomization will be conducted using a computerized program.

5. Participants will be invited to start the intervention sessions.

6. At the end of the treatment, athletes will go through post-treatment assessment.

The demographic data will be collected from eligible participants by a blinded assessor at baseline period. The included participants will be randomly allocated to tDCS groups or control group by a website (www.randomization.com) in a balanced allocation ratio. Outcome measures will be conducted by an assessor blinded to group randomization at baseline, after tDCS interventions, and at 1-month follow up. Allocation will be concealed from the assessor until the end of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• Athletes who are 12 years of age and older.

• Athletes who have a complaint of sleep impairment determined by >5 total score on Pittsburg Sleep Quality Index (PSQI).

Exclusion Criteria:

• Athletes who is using sleep medications or treatment.

• Athletes who have more than 1 concussion in the past year.

• Wearing a pacemaker.

• Pregnant athletes.

• Athletes who have repetitive migraine

• Athletes who are wearing a metal implant.

• Athletes who have epilepsy.

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Transcranial Direct Current Stimulation
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep.

Locations

Country	Name	City	State
Jordan	University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of sleep impairment (using Insomnia Severity Index)	The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).	Baseline.
Primary	Severity of sleep impairment (using Insomnia Severity Index)	The effect of the intervention on insomnia severity. The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).	After 4 weeks.
Primary	Quality of Sleep (using Actigraph activity monitor)	The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.	Baseline.
Primary	Quality of Sleep (using Actigraph activity monitor)	The effect of the intervention on quality of sleep. The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.	After 3 weeks.
Primary	Daytime sleepiness (using Epworth Sleepiness Scale)	It consists of 8 items where the subject uses a 4-point Likert scale to rate how likely they would be to fall asleep in 8 different scenarios of daily activities. The total score ranges between 0-24 with a higher score indicates worse daytime sleepiness.	Baseline.
Primary	Daytime sleepiness (using Epworth Sleepiness Scale)	The effect of the intervention on daytime sleepiness. It consists of 8 items where the subject uses a 4-point Likert scale to rate how likely they would be to fall asleep in 8 different scenarios of daily activities. The total score ranges between 0-24 with a higher score indicates worse daytime sleepiness.	After 4 weeks.
Primary	The Quality of sleep (Using Pittsburgh Sleep Quality Index)	The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.	Screening for eligibility.
Primary	The Quality of sleep (Using Pittsburgh Sleep Quality Index)	The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.	After 4 weeks.
Primary	The Quality of sleep (Using Pittsburgh Sleep Quality Index)	The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.	After 2 Months from baseline.
Secondary	The Quality of Life (using Medical Outcomes Study Short Form 12)	The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).	Baseline.
Secondary	The Quality of Life (using Medical Outcomes Study Short Form 12)	The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).	After 4 weeks.
Secondary	The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)	The effect of the intervention on anxiety, depression, and stress. The total score ranges from 0 to 63 with higher score indicates more severe anxiety, depression, and stress (worse).	Baseline.
Secondary	The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)	The effect of the intervention on anxiety, depression, and stress. The total score ranges from 0 to 63 with higher score indicates more severe anxiety, depression, and stress (worse).	After 4 weeks.