Clinical trial NCT04104880: Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure
Official title: Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled before-and-after study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)
timeFrame: Three months
measure: Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS)
timeFrame: Three months
Secondary outcomes:
measure: Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention
timeFrame: Three months
measure: Change in oxygen desaturation index (ODI) from baseline to post-intervention.
timeFrame: Three months
measure: Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
timeFrame: Three months
measure: Change in body mass index (BMI)
timeFrame: Three months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Gualberto Buela-Casal, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.