Sleep Apnea Syndromes, ObstructiveOSASDizNCT03850353
Obstructive Sleep Apnea Syndrome (OSAS) and Dizziness
An observational study of Sleep Apnea Syndromes, Obstructive and Dizziness, run by Tel-Aviv Sourasky Medical Center.
Trial summary
A total of 400 participants will be recruited: 200 patients with suspected OSAS will be recruited from the sleep clinic (OSAS group), 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sleep Apnea Syndromes, Obstructive, Dizziness, Eustachian Tube Dysfunction
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Mar 2022
- 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: Group 1 - 200 patients with OSAS based on sleep study will be recruited from the sleep clinic (OSAS group) Group 2 - 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). Group 3 - 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls).
Who may be able to join
- age 18-90 years
- Group 1: subjects diagnosed with OSAS based sleep study
- Group 2: subjects referred to the ENT clinic with major complaint of dizziness (defined as a non-spinning sensation, without illusion of movement)
- Group 3: subjects referred for the ENT or the Sleep clinic with no dizziness and no evidence of OSAS
Who cannot join
- Neurological and psychiatric disorders
- Pregnant women
- Subjects with judgment difficulties
- Subjects that will be diagnosed with specific pathology that explains their dizziness.
- Subjects previously diagnosed and treated surgically for OSAS .
- Subjects with any previous intervention on the soft palate base tongue or pharynx (not including adenotonsillectomy).
- Subjects with any congenital anomaly of the palate and pharynx
About this study
A total of 400 participants will be recruited: 200 patients with suspected OSAS will be recruited from the sleep clinic (OSAS group), 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). In addition, 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls). Informed consents will be completed by all participants. ). In order to assess the effect of treatment of OSAS on dizziness -patients with the diagnosis of OSAS will complete validated questionnaires regarding sleep, dizziness and eustachian tube function 3 months following initiation of treatment with CPAP
Read the detailed description
Group 1 - 200 patients with OSAS based on sleep study will be recruited from the sleep clinic (OSAS group) Group 2 - 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group).
Group 3 - 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls).
Informed consents will be completed by all participants. All participants will undergo thorough physical examination with particular attention to the vestibular system, otoscopy, examination of the pharynx including with a flexible endoscope (that is part of the standard ENT examination). The examiner will photo-document the nasopharynx as needed.
Demographics and complete medical history will be recorded for each participant.
All participants will complete the following validated questionnaires:
- Berlin questionnaire for OSAS
- Epworth sleepiness scale
- Dizziness Handicap Inventory - Hebrew version (DHI-H)
- Eustachian tube dysfunction questionnaire Subjects from Group 1 that will have positive dizziness/eustachian dysfunction will be referred for the ENT clinic for further evaluation. Participants with dizziness will be treated, if indicated, based on their diagnosis and according to clinical guidelines with symptoms relievers in the acute phase (medications such sulpiride; fluids, metoclopramide) , physiotherapy and thiazide diuretics for chronic conditions.
Patients from Group 2 that will have a positive Berlin questionnaire will undergo ambulatory sleep study with WatchPAT (Itamar Medical, Israel). The Berlin questionnaire consists of 10 items divided into 3 categories (category 1: items 1-5, category 2: items 6-9, category 3: item 10). A positive Berlin question (high risk for OSA) is when 2 out of the 3 categories are positive.
A patient will be diagnosed with OSAS if the Apnea-Hypopnea Index in the sleep study will be greater than 5 per hour of sleep. Patients with moderate-severe OSA (AHI greater than 15 per hour of sleep) will be treated with CPAP.
Patients from Group 3 with positive Berlin questionnaire will be referred for a sleep study as indicated in the clinical setting.
Risk factors associated with OSAS will be recorded: Age, gender, smoking, BMI, neck circumference. In addition, comorbidities associated with OSAS will be recorded such as hypertension, diabetes, hyperlipidemia, coronary artery disease and stroke.
The investigators expect 15% of the patients referred to the sleep study to be diagnosed with OSAS.
In order to assess the effect of treatment of OSAS on dizziness -patients with dizziness and diagnosis of moderate severe OSAS (AHI >15) who will be treated with CPAP will be asked to complete the 4 validated questionnaires 3 months following initiation of treatment with CPAP. CPAP use of 80% or more of total sleep time (T.S.T) will be considered as full compliance. 60-80% of T.S.T- partial compliance. <60% - no compliance.
- Medical subject headings
- Sleep Apnea Syndromes, Dizziness
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 |
|---|---|---|
| OSAS | Patients with Obstructive Sleep Apnea (AHI>15 in a sleep study) | |
| Dizziness | Patients with Dizziness (defined as a non-spinning sensation, without illusion of movement) | |
| No OSAS No Dizziness | Patients without dizziness and no evidence for OSAS (subjects referred for the ENT or the Sleep clinic with no dizziness and no evidence of OSAS ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the score on Dizziness Handicap Inventory (DHI)
The change in the total score on the DHI before and after the use of CPAP in (minimum score:0, maximum score: 100. Higher values represent worsening of the dizziness) OSAS patients
Measured: 3 months after beginning of use of CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes, ObstructiveStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850353
- Sponsor's protocol ID
- 0920-18-TLV
- Acronym
- OSASDiz
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Syndrome (OSAS) and Dizziness
- ClinicalTrials.gov ID
- NCT03850353
- Acronym / sponsor ID
- OSASDiz / 0920-18-TLV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 21 Feb 2019 (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.
A total of 400 participants will be recruited: 200 patients with suspected OSAS will be recruited from the sleep clinic (OSAS group), 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). In addition, 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls). Informed consents will be completed by all participants. ). In order to assess the effect of treatment of OSAS on dizziness -patients with the diagnosis of OSAS will complete validated questionnaires regarding sleep, dizziness and eustachian tube function 3 months following initiation of treatment with CPAP
Detailed description
Group 1 - 200 patients with OSAS based on sleep study will be recruited from the sleep clinic (OSAS group) Group 2 - 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group).
Group 3 - 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls).
Informed consents will be completed by all participants. All participants will undergo thorough physical examination with particular attention to the vestibular system, otoscopy, examination of the pharynx including with a flexible endoscope (that is part of the standard ENT examination). The examiner will photo-document the nasopharynx as needed.
Demographics and complete medical history will be recorded for each participant.
All participants will complete the following validated questionnaires:
- Berlin questionnaire for OSAS
- Epworth sleepiness scale
- Dizziness Handicap Inventory - Hebrew version (DHI-H)
- Eustachian tube dysfunction questionnaire Subjects from Group 1 that will have positive dizziness/eustachian dysfunction will be referred for the ENT clinic for further evaluation. Participants with dizziness will be treated, if indicated, based on their diagnosis and according to clinical guidelines with symptoms relievers in the acute phase (medications such sulpiride; fluids, metoclopramide) , physiotherapy and thiazide diuretics for chronic conditions.
Patients from Group 2 that will have a positive Berlin questionnaire will undergo ambulatory sleep study with WatchPAT (Itamar Medical, Israel). The Berlin questionnaire consists of 10 items divided into 3 categories (category 1: items 1-5, category 2: items 6-9, category 3: item 10). A positive Berlin question (high risk for OSA) is when 2 out of the 3 categories are positive.
A patient will be diagnosed with OSAS if the Apnea-Hypopnea Index in the sleep study will be greater than 5 per hour of sleep. Patients with moderate-severe OSA (AHI greater than 15 per hour of sleep) will be treated with CPAP.
Patients from Group 3 with positive Berlin questionnaire will be referred for a sleep study as indicated in the clinical setting.
Risk factors associated with OSAS will be recorded: Age, gender, smoking, BMI, neck circumference. In addition, comorbidities associated with OSAS will be recorded such as hypertension, diabetes, hyperlipidemia, coronary artery disease and stroke.
The investigators expect 15% of the patients referred to the sleep study to be diagnosed with OSAS.
In order to assess the effect of treatment of OSAS on dizziness -patients with dizziness and diagnosis of moderate severe OSAS (AHI >15) who will be treated with CPAP will be asked to complete the 4 validated questionnaires 3 months following initiation of treatment with CPAP. CPAP use of 80% or more of total sleep time (T.S.T) will be considered as full compliance. 60-80% of T.S.T- partial compliance. <60% - no compliance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSAS | – | –Patients with Obstructive Sleep Apnea (AHI>15 in a sleep study) |
| Dizziness | – | –Patients with Dizziness (defined as a non-spinning sensation, without illusion of movement) |
| No OSAS No Dizziness | – | –Patients without dizziness and no evidence for OSAS (subjects referred for the ENT or the Sleep clinic with no dizziness and no evidence of OSAS ) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 - 200 patients with OSAS based on sleep study will be recruited from the sleep clinic (OSAS group) Group 2 - 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). Group 3 - 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls).
Key inclusion criteria (4 listed)
- age 18-90 years
- Group 1: subjects diagnosed with OSAS based sleep study
- Group 2: subjects referred to the ENT clinic with major complaint of dizziness (defined as a non-spinning sensation, without illusion of movement)
- Group 3: subjects referred for the ENT or the Sleep clinic with no dizziness and no evidence of OSAS
Key exclusion criteria (7 listed)
- Neurological and psychiatric disorders
- Pregnant women
- Subjects with judgment difficulties
- Subjects that will be diagnosed with specific pathology that explains their dizziness.
- Subjects previously diagnosed and treated surgically for OSAS .
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
The change in the score on Dizziness Handicap Inventory (DHI)
Time frame: 3 months after beginning of use of CPAP
The change in the total score on the DHI before and after the use of CPAP in (minimum score:0, maximum score: 100. Higher values represent worsening of the dizziness) OSAS patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, Obstructive and Dizziness, run by Tel-Aviv Sourasky Medical Center.
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 7 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 28 Feb 2019. 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?
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?
The change in the score on Dizziness Handicap Inventory (DHI) (time frame: 3 months after beginning of use of CPAP). 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 28 Feb 2019.