Obstructive Sleep ApneaNCT06715228
Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea
A study testing shitali pranayama respiratory rehabilitation training in people with Obstructive Sleep Apnea, run by Cairo University at 1 site in Egypt.
Trial summary
obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- shitali pranayama respiratory rehabilitation training
- 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
- 7 Nov 2024to 15 Apr 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-obese patients
- obstructive sleep apnea (mild and moderate form)
Who cannot join
- cardiac patients metabolic diseases kidney diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
ahmed elfahl, lecturer, +201001891218, ahmed.elfahl@buc.edu.eg
About this study
obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration
Read the detailed description
in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group I and group II with an equal number of patients (n = 20 for the group). Group I will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, Group II, will act as control group.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- shitali pranayama respiratory rehabilitation training
- 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.
shitali pranayama respiratory rehabilitation trainingBehavioural
in this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | in this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, Receives: Behavioral: shitali pranayama respiratory rehabilitation training |
| Group II | No intervention | in this group, patients (n=20) with obstructive sleep apnea will participate and will act as control group. In this group, no intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea hypopnea index
it will be measured through a sleep study
Measured: it will be assessed after 12 weeks
Secondary outcomes (6)
systolic blood pressure
it will be assessed via a sphygmomnamoeter
Measured: it will be assessed after 12 weeks
diastolic blood pressure
it will be assessed via a sphygmomnamoeter
Measured: it will be assessed after 12 weeks
Pittsburg sleep quality index
it will assess sleep quality
Measured: it will be assessed after 12 weeks
respiratory rate
it will assess respiratory cycle per minute
Measured: it will be assessed after 12 weeks
Epworth sleepiness scale
it ill assess daytime sleepiness
Measured: it will be assessed after 12 weeks
visual analogue scale of by-partner reported sleep difficulty
it will assess by-partner reported sleep difficulty due to snoring of patient
Measured: it will be measured 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 posted4 Dec 2024
- Study start7 Nov 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715228
- Sponsor's protocol ID
- IRB00014233-15
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismail AMA, Gadallah NGM, Elfahl AMA. Apnea-hypopnea index, blood pressure, daytime sleepiness, and sleeping quality in obstructive sleep apnea: randomized-controlled responses to Shitali respiratory training. Respir Med. 2026 Feb;252:108608. doi: 10.1016/j.rmed.2025.108608. Epub 2025 Dec 23.
PubMed 41448283
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06715228
- Acronym / sponsor ID
- IRB00014233-15
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 4 Dec 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.
obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration
Detailed description
in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group I and group II with an equal number of patients (n = 20 for the group). Group I will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, Group II, will act as control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: shitali pranayama respiratory rehabilitation trainingin this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, |
| Group II | No intervention | –in this group, patients (n=20) with obstructive sleep apnea will participate and will act as control group. In this group, no intervention will be applied |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-obese patients
- obstructive sleep apnea (mild and moderate form)
Key exclusion criteria (1 listed)
- cardiac patients metabolic diseases kidney diseases
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 |
|---|---|---|
| shitali pranayama respiratory rehabilitation trainingin this group, patients (n=20) with obstructive sleep apnea will participate and will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance | Behavioural | group I |
Primary outcome
apnea hypopnea index
Time frame: it will be assessed after 12 weeks
it will be measured through a sleep study
6 secondary outcomes
systolic blood pressure
Time frame: it will be assessed after 12 weeks
diastolic blood pressure
Time frame: it will be assessed after 12 weeks
Pittsburg sleep quality index
Time frame: it will be assessed after 12 weeks
respiratory rate
Time frame: it will be assessed after 12 weeks
Epworth sleepiness scale
Time frame: it will be assessed after 12 weeks
visual analogue scale of by-partner reported sleep difficulty
Time frame: it will be measured after 12 weeks
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 4 Dec 2024.
- Derived from this study: PubMed 41448283Ismail AMA, Gadallah NGM, Elfahl AMA. Apnea-hypopnea index, blood pressure, daytime sleepiness, and sleeping quality in obstructive sleep apnea: randomized-controlled responses to Shitali respiratory training. Respir Med. 2026 Feb;252:108608. doi: 10.1016/j.rmed.2025.108608. Epub 2025 Dec 23.
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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.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shitali pranayama respiratory rehabilitation training in people with Obstructive Sleep Apnea, run by Cairo 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: looking for participants now, as of the sponsor's last update on 4 Dec 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?
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 Ali Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea hypopnea index (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06715228, which also lists 1 linked publication.
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 4 Dec 2024.