Mateu Serra-Prat
Mataró, Barcelona, 08304, Spain
NCT Number: NCT06507098
The objective of this trial is to evaluate the use of a video-assisted training for the use of a home-respiratory polygraph for the diagnosis of obstructive sleep apnea compared to standard training by a nurse.
A clinical trial is conducted to this effect. One arm is video-assisted training and the other arm is conventional training by a nurse.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mataró, Barcelona, 08304, Spain
Hypotheses:
Objectives:
Main objective:
Compare the number of errors in the RP record derived from poor placement of the polygraph between an in-person nursing instruction and a telematic instruction using a video.
Secondary objectives:
Study design:
Open randomized clinica trial with two arms of intervention: instruction in the functioning of the respiratory polygraph according to usual clinical practice and instruction in audiovisual media.
Study population Patients with suspected Obstructive sleep apnea (OSA) who have been indicated for performing a home respiratory polygraphy for the first time.
Study exhibition Consecutive patients with OSA who come to the Pneumology Service for the collection of a respiratory polygraph for the performance of a home PR for the first time. Recruitment is made at the time you go to collect the respiratory polygraph if you decide to participate in the study, after signing the informed consent and checking the inclusion and exclusion criteria. At that moment randomization will be made and they will be assigned to one of the two intervention groups.
Statistical analysis
The data will be registered in an electronic data base in a dissociated manner so that the analyzers will not be able to connect the identity of the persons participating in the study. The database will be stored in the CSdM information system along with standard security measures. The analysis plan includes:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received a QR code and a link for access to a YouTube video recorded to this effect where the process of setting up the respiratory polygraph was explained. The contents of the video were the same as those in the face-to-face instructions. The visualization of the video was at home, and it could be viewed as many times as necessary.
A trained nurse with long experience in home sleep studies explained the setup of the respiratory polygraph. At the end of the intervention doubts about the procedure were addressed. Patients did not have access to the video.
Time frame: 1 day
Number of studies without recording errors
Time frame: 1 day
Minutes of caregiver's time spent in the instruction
Time frame: 1 day
Satisfaction of the patients with the instruction measured by an analogic visual scale (0-10)
Consorci Sanitari del Maresme
Other
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