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

Obstructive Sleep Apnea Clinical Trial

— ADIPOSA  

Official title:

Anxiety and Depression In Patients With Obstructive Sleep Apnoea Before and After Continuous Positive Airway Pressure: the ADIPOSA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104880
• Other study ID #: ADIPOSA-19
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 14, 2019

Study information

• Verified date: September 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure (CPAP)
Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Carneiro-Barrera A, Amaro-Gahete FJ, Díaz-Román A, Guillén-Riquelme A, Jurado-Fasoli L, Sáez-Roca G, Martín-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). pii: E2227. doi: 10.3390/nu11092227. — View Citation

Carneiro-Barrera A, Díaz-Román A, Guillén-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. — View Citation

Jurádo-Gámez 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. — View Citation

Sánchez AI, Martínez P, Miró 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI)	Changes in state anxiety and trait anxiety components measured by STAI questionnaire after three-month CPAP usage	Three months
Primary	Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS)	Changes in depression symptoms measured by BDI-FS questionnaire after three-month CPAP usage	Three months
Secondary	Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention	Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention.	Three months
Secondary	Change in oxygen desaturation index (ODI) from baseline to post-intervention.	Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.	Three months
Secondary	Change in excessive daytime sleepiness (EDS) from baseline to post-intervention	Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score > 9 indicates high daytime sleepiness.	Three months
Secondary	Change in body mass index (BMI)	Change in body mass index from baseline to post-intervention	Three months