An observational study in Sleep Apnea Syndromes, Obstructive, Dizziness and Eustachian Tube Dysfunction, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
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
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:
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.
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's planned enrollment of 400 is above the median of 109 across 659 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 552 studies on the registry; 49 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with Obstructive Sleep Apnea (AHI\>15 in a sleep study)
Patients with Dizziness (defined as a non-spinning sensation, without illusion of movement)
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 )
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
Time frame: 3 months after beginning of use of CPAP
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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