NCT04321083 (O2SLEEP) is a EARLY_PHASE1 clinical trial of INVOS in Obstructive Sleep Apnea, sponsored by Tel-Aviv Sourasky Medical Center.

Who is sponsoring NCT04321083?

NCT04321083 is sponsored by Tel-Aviv Sourasky Medical Center.

What drugs are being tested in NCT04321083?

Interventions in NCT04321083: INVOS.

What condition does NCT04321083 study?

NCT04321083 studies Obstructive Sleep Apnea, Pediatric Sleep Apnea.

Is NCT04321083 still recruiting?

NCT04321083 is currently status unknown. Last updated 25 March 2020.

Last reviewed 2020-03-25 · How we verify

NCT04321083: O2SLEEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea

Status unknown EARLY_PHASE1 Last updated 25 March 2020

What this trial tests

EARLY_PHASE1 trial testing INVOS in Obstructive Sleep Apnea in 100 participants. Status unknown.

Timeline

11 September 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Tel-Aviv Sourasky Medical Center
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	11 September 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Israel

Drugs / interventions tested

INVOS

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Pediatric Sleep Apnea — all drugs for Pediatric Sleep Apnea →

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

Adults 4 to 16, any sex, with Obstructive Sleep Apnea or Pediatric Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements. Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Other Tel-Aviv Sourasky Medical Center trials

Trials by the same sponsor.

NCT07380737 — Feasibility and Preliminary Effects of the Walking Tall App for Home-Based Gait Training in Parkinson's Disease: A Pilot · NA · recruiting
NCT07104136 — Improving Adherence to COPD Treatments in Primary Care · NA · enrolling by invitation
NCT07327021 — MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC · Phase 2 · recruiting
NCT07191249 — A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previousl · Phase 2 · not yet recruiting
NCT07235332 — Assessing Toxic Metal Exposure From Vegetarian/Vegan, Omnivorous, and Low-carb Diets in Israel. · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04321083 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center
Last refreshed: 25 March 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04321083.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing