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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570738
• Other study ID #: Carmel-001
• Status: Completed
• Start date: July 2012
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age between 5-90

2. Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

Exclusion Criteria:

1. Permanent pacemaker.

2. Severe lung disease.

3. Peripheral neuropathy.

4. Finger deformity that precludes adequate sensor appliance.

5. 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).

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

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	Compare sleep data collected from the Watch-PAT device to PSG data		3 years