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

Study Overview
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Uncontrolled before-and-after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure (CPAP) group<br>Three-month CPAP use | Device: Continuous positive airway pressure (CPAP)<br>* Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Change in body mass index (BMI) | Change in body mass index from baseline to post-intervention | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea