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Status unknownNCT03850353OSASDizUpdated Feb 28, 2019

Obstructive Sleep Apnea Syndrome (OSAS) and Dizziness

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

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 90 Years
Sex
All
01

Study 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). 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:

  1. Berlin questionnaire for OSAS
  2. Epworth sleepiness scale
  3. Dizziness Handicap Inventory - Hebrew version (DHI-H)
  4. 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.

02

Conditions studied

  • Sleep Apnea Syndromes, Obstructive
  • Dizziness
  • Eustachian Tube Dysfunction
03

In context

Sleep Apnea Syndromes

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 →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 552 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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).

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 )

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03850353
Responsible party
Sponsor
First posted
Feb 21, 2019
Start date
Apr 1, 2019 (estimated)
Primary completion
Mar 31, 2022 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Feb 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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