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

Not Applicable

Not yet recruiting

• Conditions: OSA - Obstructive Sleep Apnea

• Registration Number: NCT06954974
• Lead Sponsor: King Abdulaziz University

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.

Detailed Description

"Obstructive sleep apnea" (OSA) explains upper airway blockage episodes that recur frequently as you sleep and cause sporadic hypoxia, daytime sleepiness, and impaired cognitive performance. If treatment is not received, OSA can have severe effects on the cardiovascular system and can be fatal . Obesity is one of the significant risk factors for OSA, and it is twice as common in obese individuals as in those of typical weight . Additionally, it has been shown that obesity and the apnea-hypopnea index (AHI) are correlated; a 10% rise in weight is linked to a 32% increase in the AHI . Although the Always the first treatment for Although People who have OSA require constant positive airway pressure, there is mounting evidence that weight loss can also mitigate the severity of OSA .

In Saudi Arabia, Between December 2005 and March 2006, surveys were undertaken by the University of King Khalid and the King Fahd National Guard Primary Health Clinics in Riyadh to ascertain The rate of OSA symptoms in the People of middle age. The study found that OSA symptoms were quite prevalent. One in three middle-aged Male Saudis are susceptible to OSA in the primary care setting .

The upper airway repeatedly collapsing or constricting while you sleep is the primary reason behind both apnea and hypopnea in patients with OSA. Therefore, limiting upper airway collapse may theoretically help to alleviate the problem of apnea/hypopnea during sleep. Recent research indicates that both morphological and non-anatomical variables may be involved in the upper airway collapse when you sleep . OSA can have a significant detrimental effect on life quality (QoL) and is linked to several health issues, such as daytime tiredness, exhaustion, fatigue, depression, functional and cognitive decline that can increase the duration of sedentary time, and cardiovascular diseases .

Polysomnography is the gold standard for diagnosing OSA (PSG).The majority popular and extensively used tool to assess the intensity of OSA is the apnea and hypopnea index (AHI), which PSG offers. The total of all episodes (hypopneas and apneas) divided by the number of sleep hours is the AHI. Values between 5 and 14 are classified as mild, those between 15 and 29 as a medium, and those higher Thirty as severe.

Oral-pharyngeal rehabilitation can reduce Sleep apnea and its severity in some cases by maintaining the upper airway open and improving the tensile strength, rigidity and reactivity of the neck, tongue, and muscles governing the soft palate's mobility, both intrinsic and extrinsic..These findings are supported by case-control research that showed persons with poor sleep quality had lower levels of physical activity than comparable adults without sleep issues. For example, compared to people without sleep apnea, persons with OSA had a lower likelihood of being active, and longitudinal and cross-sectional data indicate that those who exercise frequently have a lower prevalence and incidence of OSA . The fatigue and sleepiness, as well as the extra weight and poor energy characteristic of the clinical presentation of OSA and the accompanying neurocognitive changes, have been linked to the low levels of physical activity reported in these individuals.

For many rehabilitation programs, the at-home exercise regimen is crucial. . This is especially true in light of the COVID-19 epidemic, as many regions may view hospital visits for rehabilitation as superfluous. The Natural home rehabilitation, however, requires that the person completes physical therapy activities on their own, unsupervised by a licensed physical therapist or other medical experts. As a result, the patient's recollection or the helping family member or caregiver frequently account for all of the performance quality, which is not the best course of action for any physical activity program. In the therapeutic community, smartphone applications for at-home rehabilitation programs have gained a lot of attention. Numerous research have looked into how smartphone apps affect older persons' activity, fall prevention, and Parkinsonism. .

However, to our knowledge, there isn't a program, gadget, or application made to help people with OSA carry out at-home rehabilitation exercises. The OSA rehabilitation program necessitates a certain amount of ability in contrast to programs that primarily target gross motor abilities, such as those for fall prevention or Parkinson's disease. .

The aim of the present thesis 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.

In the present thesis, the investigators hypothesize that using a home-based exercise training smartphone application will improve OSA patients' outcomes, including sleep quality, fatigue, functional capacity, and quality of life among OSA patients.

Study Timeline

• Study First Submitted: 2025-01-29
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Study Start: 2025-05-25
• Primary Completion: 2025-11-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BMI	BASE LINE - 3 MONTH	(weight and height will be combined to report BMI in kg/m\^2). weight in kilograms, height in meters
Quality of Life Assessment	BASE LINE - 3 MONTH	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
Sleep Quality	BASE LINE - 3 MONTH	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
Fatigue	BASE LINE - 3 MONTH	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.
Functional Capacity	BASE LINE - 3 MONTH	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
Sleep Test Results	BASE LINE - 3 MONTH	(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.