tDCS in Improving Quality of Sleep in Athletes

NCT05318352 | Unknown DMC

• 1 other identifier: 80-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

tDCS, Sleep, Athletes

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• The Quality of Life (using Medical Outcomes Study Short Form 12)

  Baseline.

• The Quality of Life (using Medical Outcomes Study Short Form 12)

  After 4 weeks.

• The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)

  Baseline.

• The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)

  After 4 weeks.

Study Arms (2)

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.

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Sham transcranial Direct Current Stimulation (tDCS); Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

RECRUITING

Related Publications (1)

• 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.

  PMID: 36233749 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alia Alghwiri, PhD

  University of Jordan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alia Alghwiri, PhD

CONTACT

+96265355000; alia.alghwiri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 8, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)