Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

NCT01570738 | Completed

• 1 other identifier: Carmel-001
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".

Conditions

Sleep Disorders

Keywords

sleep disorders; sleep apnea; ambulatory device; polysomnography; WatchPAT

Outcome Measures

Primary Outcomes (1)

• Compare sleep data collected from the Watch-PAT device to PSG data

  3 years

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children with and without sleep disorders, referred to Carmel Medical Center clinical sleep laboratory for an overnight sleep study

You may qualify if:

• Age between 5-90
• Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

You may not qualify if:

• Permanent pacemaker.
• Severe lung disease.
• 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).

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 4, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-03

Locations

IL (1)