Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure

NCT ID: NCT04104880

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-10-14

Brief Summary

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Continuous positive airway pressure (CPAP) is the gold-standard treatment for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing in the overall population. CPAP has shown to be effective in reducing apnoea-hypopnoea index (AHI) as well as other OSA polysomnographic outcomes. However, the effectiveness of this device on OSA daily functioning and mood disturbances outcomes still remains unclear. The ADIPOSA study is aimed at determining the effects of three-month CPAP use on anxiety-depression symptoms in patients with OSA. Participants will be adults previously diagnosed with OSA who will be allocated to a CPAP-treatment group. Outcomes will be measured at baseline and intervention end-point (three months) including daytime sleepiness, daily functioning and mood (anxiety and depression symptoms), AHI, other neurophysical and cardiorespiratory polysomnographic outcomes, and body weight. ADIPOSA may serve to establish the effectiveness of CPAP on daytime functioning and mood disturbances commonly found on patients with OSA and, in turn, on other OSA outcomes related to anxiety-depression symptoms.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Uncontrolled before-and-after study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Positive Airway Pressure (CPAP) group

Three-month CPAP use

Group Type EXPERIMENTAL

Continuous positive airway pressure (CPAP)

Intervention Type DEVICE

Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

Interventions

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Continuous positive airway pressure (CPAP)

Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Previous clinical diagnosis of mild/moderate/severe OSA (AHI \> 5) by a healthcare professional
* Use of CPAP
* Motivation to participate in the study
* Willing to provide informed consent

Exclusion Criteria

* Presence of any other primary sleep disorder
* Presence of any mental disorder (including depression, anxiety, and addiction to alcohol or other substances)
* Presence of any other severe organic disease, except for those comorbid to OSA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Virgen de las Nieves

OTHER

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Almudena Carneiro Barrera

Teaching and research academic staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gualberto Buela-Casal, PhD

Role: STUDY_DIRECTOR

Universidad de Granada

Locations

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University of Granada

Granada, , Spain

Site Status

Countries

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Spain

References

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Carneiro-Barrera A, Diaz-Roman A, Guillen-Riquelme A, Buela-Casal G. Weight loss and lifestyle interventions for obstructive sleep apnoea in adults: Systematic review and meta-analysis. Obes Rev. 2019 May;20(5):750-762. doi: 10.1111/obr.12824. Epub 2019 Jan 4.

Reference Type BACKGROUND
PMID: 30609450 (View on PubMed)

Carneiro-Barrera A, Amaro-Gahete FJ, Diaz-Roman A, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Ruiz JR, Buela-Casal G. Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: Rationale, Design and Methodology of the INTERAPNEA Study. Nutrients. 2019 Sep 15;11(9):2227. doi: 10.3390/nu11092227.

Reference Type BACKGROUND
PMID: 31540168 (View on PubMed)

Sanchez AI, Martinez P, Miro E, Bardwell WA, Buela-Casal G. CPAP and behavioral therapies in patients with obstructive sleep apnea: effects on daytime sleepiness, mood, and cognitive function. Sleep Med Rev. 2009 Jun;13(3):223-33. doi: 10.1016/j.smrv.2008.07.002. Epub 2009 Feb 7.

Reference Type BACKGROUND
PMID: 19201228 (View on PubMed)

Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Effects of continuous positive airway pressure treatment on cognitive functions in patients with severe obstructive sleep apnoea. Neurologia. 2016 Jun;31(5):311-8. doi: 10.1016/j.nrl.2015.03.002. Epub 2015 May 11. English, Spanish.

Reference Type BACKGROUND
PMID: 25976943 (View on PubMed)

Other Identifiers

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ADIPOSA-19

Identifier Type: -

Identifier Source: org_study_id

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