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Sleep apnea study reveals why couples struggle with CPAP machines

NCT ID NCT07150611

Knowledge-focused Sponsor: Fondazione Don Carlo Gnocchi Onlus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at how people with obstructive sleep apnea and their bed partners adapt to CPAP therapy, a common treatment that uses a machine to keep airways open during sleep. Researchers interviewed 24 patients and their partners to understand what helps or hinders consistent use of the device. The goal was to identify psychological and relationship factors that could improve treatment adherence and quality of life for couples managing sleep apnea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

24 people

The number who actually took part.

Started

Jun 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Obstructive Sleep Apnea (OSA) patients and their bed partners at 3 different step of OSA management. The subgroups included: * (1) OSA patients and bed partners before starting CPAP therapy (T0) * (2) OSA patients and bed partners within the first year of CPAP use (T1) * (3) OSA patients and bed partners beyond one year of CPAP use (T2).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For patients: Inclusion Criteria: * Adult partcipants with mild (Apnea/Hypopnea Index, AHI between 5 and 15), moderate (AHI between 15 and 30), or severe (AHI greater than 30) OSA (Young et al., 2009), as certified by a pulmonologist at the recruitment centre, with a stable bed partner; * Participants with OSA awaiting CPAP therapy initiation, or those who are either adherent or non-adherent within the first year of CPAP use or who have been using CPAP for over a year; * Participants who provided informed consent to participate in the study; * Participants who are proficient in the Italian language. Exclusion Criteria: * Participants who did not provide informed consent to participate; * Participants who do not speak Italian; * Participants who have not been diagnosed with OSA and for whom CPAP therapy is not deemed necessary or who are not currently undergoing CPAP therapy; * Participants with OSA without a stable bed partner; * Participants with significant psychiatric comorbidities or with other significant organic pathologies where OSA is not the primary health concern, according to medical records; For bedpartners Inclusion criteria: * Bed partners in a stable relationship with an OSA patient for whom CPAP therapy adaptation has been deemed necessary or who are already adapted to CPAP therapy; * Bed partners who have provided informed consent to participate; * Bed partners who are proficient in the Italian language. Exclusion criteria: * Bed partners who did not provide informed consent; * Bed partners who do not speak Italian; * Bed partners without a stable relationship with an OSA patient for whom CPAP therapy adaptation has been deemed necessary or who are already adapted to CPAP therapy;

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSA - obstructive sleep apnea

Contacts and locations

Locations

  • IRCCS Fondazione Don Gnocchi

    Milan, MI, 20148, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.