Clinical trial NCT05318352: tDCS in Improving Quality of Sleep in Athletes
Official title: The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorder
Keywords: tDCS, Sleep, Athletes
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of sleep impairment (using Insomnia Severity Index)
timeFrame: Baseline.
measure: Severity of sleep impairment (using Insomnia Severity Index)
timeFrame: After 4 weeks.
measure: Quality of Sleep (using Actigraph activity monitor)
timeFrame: Baseline.
measure: Quality of Sleep (using Actigraph activity monitor)
timeFrame: After 3 weeks.
measure: Daytime sleepiness (using Epworth Sleepiness Scale)
timeFrame: Baseline.
measure: Daytime sleepiness (using Epworth Sleepiness Scale)
timeFrame: After 4 weeks.
measure: The Quality of sleep (Using Pittsburgh Sleep Quality Index)
timeFrame: Screening for eligibility.
measure: The Quality of sleep (Using Pittsburgh Sleep Quality Index)
timeFrame: After 4 weeks.
measure: The Quality of sleep (Using Pittsburgh Sleep Quality Index)
timeFrame: After 2 Months from baseline.
Secondary outcomes:
measure: The Quality of Life (using Medical Outcomes Study Short Form 12)
timeFrame: Baseline.
measure: The Quality of Life (using Medical Outcomes Study Short Form 12)
timeFrame: After 4 weeks.
measure: The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
timeFrame: Baseline.
measure: The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
timeFrame: After 4 weeks.
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Alia Alghwiri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Etoom M, Alwardat M, Alghwiri A, Lena F, Romigi A. Effects of Transcranial Direct Current Stimulation on Sleep in Athletes: A Protocol of a Randomized Controlled Trial. J Clin Med. 2022 Oct 5;11(19):5883. doi: 10.3390/jcm11195883.