Obstructive Sleep ApneaNCT06508190
Free Walking Exercise in Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver
A study testing continuous positive airway pressure and free walking exercise and continuous positive airway pressure in people with Obstructive Sleep Apnea and Non-alcoholic Fatty Liver, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Non-alcoholic Fatty Liver
- What is being tested?
- continuous positive airway pressure and free walking exercise and continuous positive airway pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The body mass index (BMI) < 35 kg/m2.
- obstructive sleep apnea patients with fatty liver
Who cannot join
- liver transplantation , alcoholic fatty liver, antipsychotic medications, bariatric surgery; cardiac , renal problem , liver cancer ; pregnancy,orthopedic problems, systemic diseases, respiratory dysfunctions, neurological dysfunctions.
Trial locations and contacts
1 site in 1 country.
El-gohary Ola, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
Ahram canadian university
Giza
hagar El-Hadidy, lecturer, hagarhadidy2016@gmail.com
About this study
Official title: Impact of Free Walking Exercise on Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver on Liver Enzymes, Degree of Exhaustion, and Quality of Sleep
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .
Read the detailed description
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .
- Conditions
- Obstructive Sleep Apnea, Non-alcoholic Fatty Liver
- Being tested
- continuous positive airway pressure, free walking exercise and continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureBehavioural
continuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night
free walking exercise and continuous positive airway pressureBehavioural
patients will receive continuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night. Also, patients will perform walking exercise for 30 mint, daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| continuous positive airway pressure therapy | Active comparator | The continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in this group groups must utilize the CPAP machine for 4 hours each night. Receives: Behavioral: continuous positive airway pressure |
| Free walking & continuous positive airway pressure therapy | Experimental | Each patient is required to walk 30 minutes, seven days a week for 12 weeks.
\& The continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in both groups must utilize the CPAP machine for 4 hours each night. Receives: Behavioral: free walking exercise and continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine tranaminase
serum hepatic enzyme
Measured: it will be measured after 12 weeks
Secondary outcomes (6)
Asparatate transamianse
serum hepatic enzyme
Measured: it will be measured after 12 weeks
Body mass index
it will be masusured on empty stomach and bladder
Measured: it will be measured after 12 weeks
triglycerodes
it will be meausred in plasma
Measured: it will be assessed after 12 weeks
Pittsiburg sleeping quality index
a questionnaire that wil be used for assessing sleeping quality
Measured: it will be assessed after 12 weeks
fatigue severity scale
a questionnaire that wil be used for assessing fatigue
Measured: it will be assessed after 12 weeks
Epworth sleepness scale
a questionnaire that wil be used for daytime sleepness
Measured: it will be assessed after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start12 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Forty patients suffering from obstructive sleep apnea are divided into two groups: one for CPAP and the other for CPAP and free walking program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed El-Hadidy, Ahram Canadian University
- Investigators
- El-Hadidy Hagar, Principal investigator, Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508190
- Sponsor's protocol ID
- 03202405263221
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 18 Jul 2024
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Free Walking Exercise on Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver on Liver Enzymes, Degree of Exhaustion, and Quality of Sleep
- ClinicalTrials.gov ID
- NCT06508190
- Acronym / sponsor ID
- 03202405263221
- Conditions
- Obstructive Sleep Apnea, Non-alcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jul 2024 (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.
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .
Detailed description
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Forty patients suffering from obstructive sleep apnea are divided into two groups: one for CPAP and the other for CPAP and free walking program.
| Arm | Type | Receives |
|---|---|---|
| continuous positive airway pressure therapy | Active comparator | Behavioral: continuous positive airway pressureThe continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in this group groups must utilize the CPAP machine for 4 hours each night. |
| Free walking & continuous positive airway pressure therapy | Experimental | Behavioral: free walking exercise and continuous positive airway pressureEach patient is required to walk 30 minutes, seven days a week for 12 weeks. \& The continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in both groups must utilize the CPAP machine for 4 hours each night. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The body mass index (BMI) < 35 kg/m2.
- obstructive sleep apnea patients with fatty liver
Key exclusion criteria (1 listed)
- liver transplantation , alcoholic fatty liver, antipsychotic medications, bariatric surgery; cardiac , renal problem , liver cancer ; pregnancy,orthopedic problems, systemic diseases, respiratory dysfunctions, neurological dysfunctions.
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 |
|---|---|---|
| continuous positive airway pressurecontinuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night | Behavioural | continuous positive airway pressure therapy |
| free walking exercise and continuous positive airway pressurepatients will receive continuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night. Also, patients will perform walking exercise for 30 mint, daily for 12 weeks | Behavioural | Free walking & continuous positive airway pressure therapy |
Primary outcome
Alanine tranaminase
Time frame: it will be measured after 12 weeks
serum hepatic enzyme
6 secondary outcomes
Asparatate transamianse
Time frame: it will be measured after 12 weeks
Body mass index
Time frame: it will be measured after 12 weeks
triglycerodes
Time frame: it will be assessed after 12 weeks
Pittsiburg sleeping quality index
Time frame: it will be assessed after 12 weeks
fatigue severity scale
Time frame: it will be assessed after 12 weeks
Epworth sleepness scale
Time frame: it will be assessed after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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. This study is not recruiting at the moment.
El-gohary Ola, PHD contact
El-Hadidy Hagar principal investigator
Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure and free walking exercise and continuous positive airway pressure in people with Obstructive Sleep Apnea and Non-alcoholic Fatty Liver, run by Ahram Canadian University at 1 site in Egypt.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Hadidy Hagar, PHD (00201007453552, hagarhadidy2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine tranaminase (time frame: it will be measured after 12 weeks). 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 18 Jul 2024.