| Outcome Measures: |
Primary: International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria, The IRLSSG is a validated and reliable questionnaire. Well-trained physicians will aid patients in completing this questionnaire and perform clinical examination. It consists of five yes/no questions, subjects will be considered to have RLS if their answers are yes to all five questions, in screening|Stop Bang, The STOP-Bang questionnaire includes the four questions used in the STOP questionnaire plus four additional demographic queries, for a total of eight dichotomous (yes/no) questions related to the clinical features of sleep apnea (snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference and male gender). For each question, answering "yes" scores 1, a "no" response scores 0, and the total score ranges from 0 to 8. Low Risk: Yes to 0 - 2 questions Intermediate Risk: Yes to 3 - 4 questions High Risk: Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI \> 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 16 inches / 40cm, in screening|Hemoglobin, Participants with normal levels between 12 - 15 g/dl Participants with levels below 12 or above 15 will be considered abnormal, in screening|Changes in The International Restless Leg Syndrome Study Group (IRLSSG) rating scale for restless legs syndrome, That consists of 10 questions scored from 0-4 with a total score ranging from 0-40 in which RLS severity is directly proportional to the total score. Meaning the higher the score, the worse and severe the symptoms., base line then once weekly for 12 weeks|Epworth sleepiness scale (ESS), It is a self-administered questionnaire that measures the severity of excessive daytime sleepiness (EDS) containing 8 questions, each question is given a score from 0 to 3 with a total score of 0-24. A score above 10 is considered abnormal i.e. in keeping with EDS, base line then once every 4 weeks for 12 weeks|Medical Outcomes Study Sleep Scale (MOS), A 12-item scale that investigates six factors including; sleep initiation, respiratory problems, maintenance, perceived adequacy and somnolence. With higher score indicating higher sleep disturbance., base line then once every 4 weeks for 12 weeks|Suggested Immobilization Test (SIT), prior to the sleep recording. at 45-degree angle with their legs outstretched. avoid moving voluntarily for the entire duration of the test. Surface EMG from the left and right anterior tibialis muscles is used to quantify leg movements. The latter are scored according to the criteria (movements lasting between 0.5 and 10 seconds, separated by intervals of 4 to 90 seconds and arising in series of at least 4 consecutive movements). The SIT periodic leg movements index represents the number of periodic leg movements per hour of immobility. Patients report severity of leg discomfort on a visual analogue scale (VAS) ranging from 0 (no discomfort) to 100 (extreme discomfort) every 10 minutes during the SIT. The mean leg discomfort score is assessed using the average of the 7 values, as well as the discomfort severity at the end of the test (time 60 minutes), the maximum leg discomfort during the test, and the variation between the lowest and the highest values recorded during the test, base line then once every 4 weeks for 12 weeks|Restless Leg Syndrome (RLS) Symptoms Diary, The (RLS) Symptom Diary is a convenient tool to record information on your daily (RLS) symptoms, their duration, sleep patterns and possible triggers such as nicotine, alcohol or caffeine. to identify what influences, triggers or worsen the (RLS) symptoms, base line then daily for the last 2 weeks|Polysomnography, Polysomnography (SOMNO Medics Plus; SOMNOmedics, Randersacker, Germany) consists of continuous recordings from surface leads for electroencephalography (EEG), electrooculography, electromyography (submental and bilateral anterior tibialis muscles), electrocardiography, nasal pressure, nasal and oral airflow (thermocouple), chest and abdominal impedance belts for respiratory muscle efforts, pulse oximetry for oxygen saturation and pulse rate, a tracheal microphone for snoring, and body position sensors for sleep position. PSG records are scored manually according to the American Academy of Sleep Medicine (AASM) 2020 scoring, base line then once every 4 weeks for 12 weeks|Hemoglobin A1C, Participants will be considered normal if the level is within 4.2 - 6.3 % Participants with a level higher than 6.3% will be considered abnormal, In screening|Vitamin D, Participants will be considered normal if the level is within 75 - 250 nmol/L Participants will be considered abnormal if the level is less than 75 or higher than 250 nmol/L, In screening|Serum Iron, Participants will be considered normal if the level is within 6 - 26 umol/L, In screening|Total Iron Binding Capacity, Participants will be considered normal if the level is within 25 - 92 umol/L, In screening|Ferritin, Participants will be considered normal if the level is within 13-150 ng/ml, In screening|Magnesium, Participants will be considered normal if the level is within 1.7 - 2.2 mg/dL, In screening |
|
