Effectiveness of Telematic Instruction to Patients in the Correct Performance of Respiratory Polygraphy at Home

NCT06507098 | Completed

• 1 other identifier: 13/23
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Number of valid respiratory polygraphies

  Number of studies without recording errors

  1 day

Secondary Outcomes (2)

• Personal care time used in the training of the procedure

  1 day

• Satisfaction with the instruction

  1 day

Study Arms (2)

Video-assisted training

EXPERIMENTAL

Patients received a QR code and a link for access to a YouTube video recorded where the process of setting up the respiratory polygraph was explained.

Other: Video-assisted training

Nurse training

PLACEBO COMPARATOR

A trained nurse with long experience in home sleep studies explained the setup of the Respiratory Polygraph.

Other: Nurse training

Interventions

Video-assisted training OTHER

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.

Video-assisted training

Nurse training OTHER

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.

Nurse training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years of age with a clinical suspicion of obstructive sleep apnea who had never undergone respiratory polygraphy

You may not qualify if:

• physical, mental or instrumental impairment for video-assisted training;
• the absence of a third person who could collaborate in the setup of the RP;
• the absence of internet connections;
• misunderstanding of Catalan or Spanish languages

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (1)

Mateu Serra-Prat

Mataró, Barcelona, 08304, Spain

Location

Study Officials

• Alejandro Robles, MD PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pneumology Department

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 18, 2024
• Study Start: May 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)