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tDCS in Improving Quality of Sleep in Athletes (tDCS)

Primary Purpose

Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring tDCS, Sleep, Athletes

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of JordanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation (tDCS)

Sham transcranial Direct Current Stimulation (tDCS)

Arm Description

Athletes with poor sleep quality will receive tDCS over the right and left prefrontal cortex (F3 and F4 areas) with a constant current of 1.5 mA intensity that lasts for 20 minutes, 3 times a week for 2 weeks in daytime.

Athletes with poor sleep quality will receive sham tDCS over the right and left prefrontal cortex.

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
March 4, 2022
Last Updated
July 7, 2023
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05318352
Brief Title
tDCS in Improving Quality of Sleep in Athletes
Acronym
tDCS
Official Title
The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Institutional Review Board approval was sought out from University of Jordan before the beginning of the study. Informed consent will be obtained from athletes guaranteed their approval to participate in the study. To insure the privacy of participants, every athlete will be assigned a study identification number. 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: Eligible athletes will be approached via the Jordanian Olympic Committee to participate in this study. A researcher will explain the whole procedures of the research study including the randomization. Athletes will go through baseline assessment. A randomization will be conducted using a computerized program. Participants will be invited to start the intervention sessions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
tDCS, Sleep, Athletes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation (tDCS)
Arm Type
Experimental
Arm Description
Athletes with poor sleep quality will receive tDCS over the right and left prefrontal cortex (F3 and F4 areas) with a constant current of 1.5 mA intensity that lasts for 20 minutes, 3 times a week for 2 weeks in daytime.
Arm Title
Sham transcranial Direct Current Stimulation (tDCS)
Arm Type
Sham Comparator
Arm Description
Athletes with poor sleep quality will receive sham tDCS over the right and left prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of sleep impairment (using Insomnia Severity Index)
Description
The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).
Time Frame
Baseline.
Title
Severity of sleep impairment (using Insomnia Severity Index)
Description
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).
Time Frame
After 4 weeks.
Title
Quality of Sleep (using Actigraph activity monitor)
Description
The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.
Time Frame
Baseline.
Title
Quality of Sleep (using Actigraph activity monitor)
Description
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.
Time Frame
After 3 weeks.
Title
Daytime sleepiness (using Epworth Sleepiness Scale)
Description
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.
Time Frame
Baseline.
Title
Daytime sleepiness (using Epworth Sleepiness Scale)
Description
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.
Time Frame
After 4 weeks.
Title
The Quality of sleep (Using Pittsburgh Sleep Quality Index)
Description
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.
Time Frame
Screening for eligibility.
Title
The Quality of sleep (Using Pittsburgh Sleep Quality Index)
Description
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.
Time Frame
After 4 weeks.
Title
The Quality of sleep (Using Pittsburgh Sleep Quality Index)
Description
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.
Time Frame
After 2 Months from baseline.
Secondary Outcome Measure Information:
Title
The Quality of Life (using Medical Outcomes Study Short Form 12)
Description
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).
Time Frame
Baseline.
Title
The Quality of Life (using Medical Outcomes Study Short Form 12)
Description
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).
Time Frame
After 4 weeks.
Title
The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
Description
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).
Time Frame
Baseline.
Title
The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
Description
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).
Time Frame
After 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alia Alghwiri, PhD
Phone
+96265355000
Ext
23200
Email
alia.alghwiri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alia Alghwiri, PhD
Organizational Affiliation
University of Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alia A. Alghwiri
Phone
0798525162
Email
ALIA.ALGHWIRI@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36233749
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.
Results Reference
derived

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tDCS in Improving Quality of Sleep in Athletes

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