OSAOSANCT02976207
Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment
An observational study of OSA, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- OSA
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.
Who may be able to join
- Fully diagnosed patients with OSA.
- Patients who are candidates for a surgery as a treatment to their condition.
Who cannot join
- Pregnancy
- Patients who are not OSA surgery candidates.
- Patients with high surgical risk.
- Patients with hematological or oncological background.
Trial locations and contacts
1 site in 1 country.
About this study
Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment
Read the detailed description
Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed
.)OSA(sleep apnea
- Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. Our results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. We think that the weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction. Our results till now show tailored surgery based on DISE may leverage sleep surgeries outcome significantly presenting 70% success rate based
- on our experience We therefore want to evaluate the patients in a long follow up period
- Conditions
- OSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA diagnosed patients | patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire
Measured: up to 3 years after surgery
Sleep quality assessment questionnaire
Measured: up to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976207
- Sponsor's protocol ID
- 55-2015
- Acronym
- OSA
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment
- ClinicalTrials.gov ID
- NCT02976207
- Acronym / sponsor ID
- OSA / 55-2015
- Conditions
- OSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- 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.
Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment
Detailed description
Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed
.)OSA(sleep apnea
- Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. Our results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. We think that the weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction. Our results till now show tailored surgery based on DISE may leverage sleep surgeries outcome significantly presenting 70% success rate based
- on our experience We therefore want to evaluate the patients in a long follow up period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA diagnosed patients | – | –patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.
Key inclusion criteria (2 listed)
- Fully diagnosed patients with OSA.
- Patients who are candidates for a surgery as a treatment to their condition.
Key exclusion criteria (4 listed)
- Pregnancy
- Patients who are not OSA surgery candidates.
- Patients with high surgical risk.
- Patients with hematological or oncological background.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire
Time frame: up to 3 years after surgery
Sleep quality assessment questionnaire
Time frame: up to 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 4 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 30 Nov 2016. 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 Israel. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire (time frame: up to 3 years after surgery). The study lists 2 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 30 Nov 2016.