Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01929447
Other study ID # Carmel-002
Secondary ID
Status Completed
Phase N/A
First received August 20, 2013
Last updated September 18, 2014
Start date October 2013

Study information

Verified date September 2014
Source Itamar-Medical, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 90 Years
Eligibility Inclusion Criteria:

- Age between 5-90

- Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion Criteria:

- Permanent pacemaker.

- Severe lung disease.

- Severe peripheral neuropathy.

- Finger deformity that precludes adequate sensor appliance.

- Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Carmel Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Itamar-Medical, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep respiratory parameters pRDI, pAHI, ODI 3 years No
See also
  Status Clinical Trial Phase
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT00990106 - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00163670 - The Impact of Sleep Disorders on Motor Vehicle Accidents N/A
Completed NCT00203827 - Pediatric Sleep Questionnaire: Use for Collection of Clinical Data N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Terminated NCT00750919 - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) Phase 3
Completed NCT02939586 - The Effect of Haemodialysis in Sleep Apnoea N/A
Completed NCT03075241 - Z-Drugs for Sleep Disorders in Alzheimer's Disease Phase 3
Completed NCT03055156 - Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms N/A
Completed NCT02585609 - Sleep Quality in Patients With Advanced Cancer N/A
Completed NCT02156128 - Subjective Memory Complaints, Objective Memory Performance and Cognitive Training N/A
Completed NCT01906866 - Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities Phase 3
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT01220401 - Efficacy of a Brief Nightmare Treatment for Veterans N/A
Completed NCT01256983 - Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation Phase 0
Not yet recruiting NCT00749814 - Sleep Disturbances in Hospitalized Children Phase 4
Completed NCT00518986 - Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression Phase 4
Completed NCT00397930 - Yoga in Treating Sleep Disturbance in Cancer Survivors Phase 2