OSA - Obstructive Sleep ApneaNCT06954974
SMARTPHONE APPLICATION HOME-BASED EXERCISES IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH
A study testing CPAP device, CPAP device and exercise and Exercise in people with OSA - Obstructive Sleep Apnea, run by King Abdulaziz University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- CPAP device, CPAP device and exercise and Exercise
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF SMARTPHONE APPLICATION HOME-BASED EXERCISES ON SLEEP QUALITY, FATIGUE, FUNCTIONAL CAPACITY, AND QUALITY OF LIFE IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH
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.
Read the 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
- Being tested
- CPAP device, CPAP device and exercise, Exercise
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP deviceDevice
CPAP device
CPAP device and exerciseDevice
CPAP device
ExerciseOther
- Retropalatal level: Phase I: • Open your mouth • Pronounce "A" for 5 seconds • Stop. Close your mouth. Procedure: 2 sets of 10 repetitions.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| exercise alone | Experimental | Not described Receives: Other: Exercise |
| CPAP device and exercise. | Experimental | Not described Receives: Device: CPAP device and exercise |
| CPAP device alone | Experimental | Not described Receives: Device: CPAP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: BASE LINE - 3 MONTH
BMI
(weight and height will be combined to report BMI in kg/m^2). weight in kilograms, height in meters
Measured: BASE LINE - 3 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanad Ayfan, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954974
- Sponsor's protocol ID
- physical therapy and osa
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2025
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF SMARTPHONE APPLICATION HOME-BASED EXERCISES ON SLEEP QUALITY, FATIGUE, FUNCTIONAL CAPACITY, AND QUALITY OF LIFE IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH
- ClinicalTrials.gov ID
- NCT06954974
- Acronym / sponsor ID
- physical therapy and osa
- Conditions
- OSA - Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise alone | Experimental | Other: Exercise |
| CPAP device and exercise. | Experimental | Device: CPAP device and exercise |
| CPAP device alone | Experimental | Device: CPAP device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP deviceCPAP device | Device | CPAP device alone |
| CPAP device and exerciseCPAP device | Device | CPAP device and exercise. |
| Exercise1. 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 | Other | exercise alone |
Primary outcome
Quality of Life Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
BMI
Time frame: BASE LINE - 3 MONTH
(weight and height will be combined to report BMI in kg/m^2). weight in kilograms, height in meters
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP device, CPAP device and exercise and Exercise in people with OSA - Obstructive Sleep Apnea, run by King Abdulaziz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MOHANAD AYFAN (+966563376526, MOHANAD.AYFAN@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Assessment (time frame: BASE LINE - 3 MONTH). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.