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

NCT ID: NCT06954974

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-25
• Study Completion Date: 2025-12-25

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.

Conditions

OSA - Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

exercise alone

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

CPAP device and exercise.

Group Type: EXPERIMENTAL

CPAP device and exercise

Intervention Type: DEVICE

CPAP device

CPAP device alone

Group Type: EXPERIMENTAL

CPAP device

Intervention Type: DEVICE

CPAP device

Interventions

CPAP device

CPAP device

Intervention Type: DEVICE

CPAP device and exercise

CPAP device

Intervention Type: DEVICE

Exercise

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Mohanad Ayfan

MOHANAD AYFAN, Coordinator Physical Therapy Track. Faculty of Medical Rehabilitation Sciences, KAU, KSA.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

MOHANAD AYFAN

Role: CONTACT

MOHANAD.AYFAN@GMAIL.COM

+966563376526

Other Identifiers

physical therapy and osa

Identifier Type: -

Identifier Source: org_study_id