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CompletedNCT06458777Updated Jun 20, 2024

Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

An observational study in Obstructive Sleep Apnea, sponsored by Hospital San Pedro de Logroño. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Hospital San Pedro de Logroño · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,144
Ages
18 Years and older
Sex
All
01

Study summary

Obstructive sleep apnea (OSA) is a chronic pathology that affects more than 20% of the adult population. It is one of the main sleep disorders with great clinical, economic and social repercussions.

To assess the impact and severity of obstructive sleep apnea, the number of apneas and hypopneas per hour (AHI) is counted. To define that a person has OAS, a sleep study must have an AHI ≥15/h, predominantly obstructive, or the presence of an AHI ≥5/h accompanied by symptoms.

The diagnosis of certainty or exclusion, as well as the severity, is established with a sleep study. Polysomnography (PSG) continues to be the gold standard for the diagnosis of OSA, it encompasses the recording of cardiorespiratory and neurophysiological variables, which makes it possible to analyze sleep time and structure, the presence of different respiratory episodes and their repercussions. Respiratory polygraphy (RP) includes recording from a flow sensor, respiratory effort, oxygen saturation, heart rate, and also position but not EEG. There are several studies that have explored the diagnostic agreement of RP versus PSG, being a validated, useful and necessary test for the diagnosis of OSA in different clinical situations. Being cheaper and more accessible.

When talking about the diagnosis of OSA, it refers to establishing whether or not there is, the severity and the therapeutic decision that will greatly affect the quality of life, prognosis and day-to-day life of the patient, since it is a chronic disease.

It must be borne in mind that most studies are carried out in a field specialized in dream interpretation, so caution must be exercised in interpreting results in another field. PR teams incorporate increasingly better developed software that allows automatic analysis of records, but the technology and algorithms used vary depending on the device, and up to now the AASM continues to recommend manual analysis based on existing evidence. Several studies have examined the agreement between automatic and manual analysis of the PR record or between automatic analysis of PR and PSG. It seems that this agreement is reached above all in the highest AHIs, above 25-30, which may limit its use in clinical practice.

For this reason, it is important to carry out a study with a large number of patients to achieve statistical significance, and strong conclusions that support normal clinical practice, and to disable a study that does not meet the scientific requirements when interpreting and reading.

02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 3,144 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Hospital San Pedro de Logroño is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Dream Unit Patients with diagnostic suspicion of OSA

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

  • Respiratory polygraphs carried out at the San Pedro Hospital in the period of time between 2014-2020.
  • Polygraphs corresponding to patients over 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Poor technical quality of polygraphy
  • Patients with >50% central apnea or presence of Cheyne-Stokes respiration (CSResp).
  • Lack of automatic and/or manual analysis of the polygraph.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,144 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients diagnosed with manual report of polygraphy

    Diagnostic Test: poligraphy

  • Patients diagnosed with automatical report of polygraphy

    Diagnostic Test: poligraphy

Interventions

  • Diagnostic testpoligraphy

    OSA diagnosis

06

What researchers measure

Primary outcomes

  1. Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

    effectiveness of the analysis described with the AHI (number of sleep apneas in each hour slept)

    Time frame: 2 years

  2. Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

    economic cost (measured in euros) of manual and automatic polygraphy

    Time frame: 2 years

07

Study locations

1 site
  • Hospital San Pedro
    Logroño, La Rioja 26006, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2014 to primary completion in Mar 2020, 74 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2023
First posted
Jun 14, 2024
StartActual
Jan 19, 2014
Primary completionActual
Mar 28, 2020
CompletionActual
Mar 15, 2023
Last update
Jun 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458777
Lead sponsor
Hospital San Pedro de Logroño
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jan 19, 2014
Primary completion
Mar 28, 2020
Completion
Mar 15, 2023
Last update
Jun 20, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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