Sleep DisordertDCSNCT05318352
tDCS in Improving Quality of Sleep in Athletes
A study testing Transcranial Direct Current Stimulation in people with Sleep Disorder, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
University of Jordan
Amman, 11942
Alia A. Alghwiri, 0798525162, ALIA.ALGHWIRI@GMAIL.COM
About this study
Official title: The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sleep Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, Sleep, Athletes
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Sham transcranial Direct Current Stimulation (tDCS) | Sham comparator | Athletes with poor sleep quality will receive sham tDCS over the right and left prefrontal cortex. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline.
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).
Measured: After 4 weeks.
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.
Measured: Baseline.
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.
Measured: After 3 weeks.
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.
Measured: Baseline.
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.
Measured: After 4 weeks.
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.
Measured: Screening for eligibility.
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.
Measured: After 4 weeks.
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.
Measured: After 2 Months from baseline.
Secondary outcomes (4)
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).
Measured: Baseline.
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).
Measured: After 4 weeks.
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).
Measured: Baseline.
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).
Measured: After 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia A. Alghwiri, University of Jordan
- Investigators
- Alia Alghwiri, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318352
- Sponsor's protocol ID
- 80-2021
- Acronym
- tDCS
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36233749
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05318352
- Acronym / sponsor ID
- tDCS / 80-2021
- Conditions
- Sleep Disorder
- Keywords
- tDCS, Sleep, Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: Transcranial Direct Current StimulationAthletes 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. |
| Sham transcranial Direct Current Stimulation (tDCS) | Sham comparator | Device: Transcranial Direct Current StimulationAthletes with poor sleep quality will receive sham tDCS over the right and left prefrontal cortex. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationTranscranial 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. | Device | Sham transcranial Direct Current Stimulation (tDCS), Transcranial Direct Current Stimulation (tDCS) |
Primary outcome
Severity of sleep impairment (using Insomnia Severity Index)
Time frame: Baseline.
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)
Time frame: After 4 weeks.
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)
Time frame: Baseline.
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)
Time frame: After 3 weeks.
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)
Time frame: Baseline.
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)
Time frame: After 4 weeks.
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)
Time frame: Screening for eligibility.
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)
Time frame: After 4 weeks.
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)
Time frame: After 2 Months from baseline.
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.
4 secondary outcomes
The Quality of Life (using Medical Outcomes Study Short Form 12)
Time frame: Baseline.
The Quality of Life (using Medical Outcomes Study Short Form 12)
Time frame: After 4 weeks.
The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
Time frame: Baseline.
The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)
Time frame: After 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Derived from this study: PubMed 36233749Etoom 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.
- Individual participant dataSharing planned: No
Related trials for Sleep Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alia Alghwiri, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Sleep Disorder, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alia Alghwiri, PhD (+96265355000 ext. 23200, alia.alghwiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of sleep impairment (using Insomnia Severity Index) (time frame: Baseline.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.