SMARTPHONE APPLICATION HOME-BASED EXERCISES IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH

NCT06954974 | Not Yet Recruiting

• 1 other identifier: physical therapy and osa
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aim is to explore the effects of a home-based exercise training smartphone application on sleep quality, fatigue, functional capacity, and quality of life among obstructive sleep apnea (OSA) patients in Jeddah city, Saudi Arabia.

Conditions

OSA - Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (6)

• Quality of Life Assessment

  The Short Form 36 (SF-36) questionnaire was used to measure the Health-Related Quality of Life (HRQOL) at baseline and at follow-up. The SF-36 was selected because of its capacity to assess quality of life in both physical and psychological domains. It is considered a standard instrument for evaluating HRQOL and was created by Ware and Sherbourne in the United States. The 36 items on the questionnaire are broken down into eight domains. The ability to carry out daily tasks including walking, taking care of oneself, and relaxing is assessed by the Physical Functioning (PF) domain, which comprises items 3 through 11. The role restrictions due to physical problems (RP) domain, which includes items 12 through 15, looks at how role constraints and everyday activities are impacted by physical issues. Items 20 to 21 make up the Bodily Pain (BP) domain, which gauges how much pain has interfered with everyday activities and how severe it has been throughout the previ

  BASE LINE - 3 MONTH

• Sleep Quality

  The Pittsburgh Sleep Quality Index (PSQI), created by Buysse et al., was used to evaluate the quality of sleep in each group. The PSQI is a self-reported instrument that assesses seven aspects of sleep quality over a month: subjective sleep quality, sleep latency, length, habitual sleep efficiency, sleep disruptions, use of sleep aids, and dysfunction during the day. The majority of the 19 items on the PSQI are answered on a Likert scale. Component scores, which range from 0 to 3, are produced by combining these items. A score of "0" indicates no sleep issues at all and score of "3" denotes serious sleep issues. For instance, the daytime dysfunction score is calculated from two items: the frequency of medication use for sleep and the frequency of trouble staying awake during daily activities such as driving or eating. These items are coded on a scale of 0 to 3 (0 = no issues, 1-2 = mild issues, 3-4 = moderate issues, 5-6 = severe issues). The subjective sleep quali

  BASE LINE - 3 MONTH

• Fatigue

  The Fatigue Severity Scale (FSS) was used to measure the patient's level of fatigue.. Each of the nine FSS items, which rate the degree of fatigue symptoms and their impact on patient functioning (such as motivation, exercise, physical functioning, carrying out duties, and interfering with work, family, or social life), is given a score between 1 (completely disagree) and 7 (completely agree). The questions include statements like "my fatigue is very debilitating" and "exercise brings on my fatigue." For every item, a higher score denotes a higher level of fatigue. All patients who responded to at least half of the FSS items had their scores determined using the conventional scoring procedure for the FSS, which involves averaging the nine items to provide an overall score that ranges from 1 (no fatigue) to 7 (very severe fatigue). A FSS average score of \< 4 is considered non fatigue, while a score ≥ 4 indicates fatigue.

  BASE LINE - 3 MONTH

• Functional Capacity

  The 6-minute walk test (6MWT) is a widely utilized tool for assessing functional exercise capacity, particularly in patients with moderate to severe cardiovascular conditions. This test was employed in this study to measure the patients' functional capacity. The 6MWT is a straightforward and practical test that only requires a 100-foot hallway, with no specialized exercise equipment or advanced training for the administering technicians. Since walking is a common activity for nearly all patients, except those with severe impairments, the test measures the maximum distance a patient can walk in six minutes on a flat, hard surface. It evaluates the combined responses of various systems involved in exercise, including the pulmonary, cardiovascular, and peripheral circulatory systems, blood, neuromuscular units, and muscle metabolism. Unlike maximal cardiopulmonary exercise testing, the 6MWT does not provide detailed insights into the function of individual organs or

  BASE LINE - 3 MONTH

• Sleep Test Results

  (AHI): The total number of apnea and hypopnea episodes that transpire throughout each hour of sleep is known as the AHI. A considerable decrease in breathing lasting at least 10 seconds is known as a hypopnea, while a total stop or cessation of breathing lasting at least 10 seconds is known as an apnoea. When combined, apnea and hypopnea cause mini-awakenings and oxygen level dips that interfere with sleep. The frequency of apnea and hypopnea per hour is a measure of the severity of sleep apnea. It is classified as normal (0-5 events/hour), mild (5-15 events/hour), moderate (15-30 events/hour), and severe (\> 30 events/hour) by the American Academy of Sleep Medicine (AASM). Sleep Efficiency: The percentage of time spent sleeping compared to the amount of time spent in bed is known as sleep efficiency. The percentage is computed by dividing the total amount of time spent in bed by the total amount of sleep. A sleep efficiency of 80% or above is regarded as normal.

  BASE LINE - 3 MONTH

• BMI

  (weight and height will be combined to report BMI in kg/m\^2). weight in kilograms, height in meters

  BASE LINE - 3 MONTH

Study Arms (3)

exercise alone

EXPERIMENTAL

Other: Exercise

CPAP device and exercise.

EXPERIMENTAL

Device: CPAP device and exercise

CPAP device alone

EXPERIMENTAL

Device: CPAP device

Interventions

CPAP device DEVICE

CPAP device

CPAP device alone

CPAP device and exercise DEVICE

CPAP device

CPAP device and exercise.

Exercise OTHER

1. Retropalatal level: Phase I: • Open your mouth • Pronounce "A" for 5 seconds • Stop. Close your mouth. Procedure: 2 sets of 10 repetitions. 2. Retroglossal level: Phase I: • Push the tongue against the front of the palate • Move it back to perform a "click" sound, Phase II: • Move the tongue from right to left and from up to down The sequence of movement directions can be randomized to increase the challenge for repetitions., Phase III: • In this exercise, the tongue of the patient will scroll • Circle with the tongue on the inside of the lips • Draw 10 circles per set. Phase IV: • pressing the back of the tongue firmly on the oral cavity's floor for 8 seconds. Phase V: • Step 1, bite the tongue depressor. • Step 2, push the tongue against the tongue depressor and hold for 8 seconds. Procedure: 2 sets of 10 repetitions. 3. Deglutition level: Phase I: • Gently hold the tongue between the front teeth • Maintain this position Then, close your mouth and swallow. Phase II: • This vers

exercise alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with confirmed mild or moderate OSA
• aged between 18 and 65 years
• BMI ≤ 40 kg/m2
• agreed to participatein the study were recruited.

You may not qualify if:

• Pregnant patients
• individuals younger than 18 or older than 65
• those who refused to participate in the study
• those with severe cardiopulmonary conditions such as chronic obstructive pulmonary disease or heart failure
• those with head and neck anomalies
• those with a BMI \>40 kg/m² were excluded from the study.

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

MOHANAD AYFAN

CONTACT

+966563376526; MOHANAD.AYFAN@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MOHANAD AYFAN, Coordinator Physical Therapy Track. Faculty of Medical Rehabilitation Sciences, KAU, KSA.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: May 2, 2025
• Study Start: May 25, 2025
• Primary Completion: November 25, 2025
• Study Completion: December 25, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04