Lifestyle Intervention for OSA in Adults

Obstructive Sleep Apnea Clinical Trial

Official title:

Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851653
• Other study ID #: INTERAPNEA-2019
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 30, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional.

• Male patients aged between 18-65 years.

• Body mass index > 25 kg/m2.

• Use of CPAP

• Motivation to participate in the study.

• Signed informed consent form.

Exclusion Criteria:

• Sleep disorder other than OSA

• Clinically significant psychiatric, neurological, or medical disorders other than OSA

• Use of prescription drugs or clinically significant drugs affecting sleep

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Lifestyle Intervention
Cognitive-behavioural intervention for weight loss and lifestyle change

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Aiello KD, Caughey WG, Nelluri B, Sharma A, Mookadam F, Mookadam M. Effect of exercise training on sleep apnea: A systematic review and meta-analysis. Respir Med. 2016 Jul;116:85-92. doi: 10.1016/j.rmed.2016.05.015. Epub 2016 May 21. Review. — View Citation

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

Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28. — 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 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.	Post-intervention (2 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.	Post-intervention (2 months)
Secondary	Change in oxygen saturation (SaO2) mean from baseline to post-intervention	Change in the average of oxygen saturation from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in oxygen saturation (SaO2) nadir from baseline to post-intervention	Minimum oxygen saturation from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in sleep efficiency from baseline to post-intervention	Change in the total sleep time/total time in bed from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in light sleep (N1 and N2 stages) from baseline to post-intervention	Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in deep sleep (N3 stage) from baseline to post-intervention	Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in rapid eye movement (REM) sleep from baseline to post-intervention	Change in the percentage of REM sleep from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.	Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.	Post-intervention (2 months)
Secondary	Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.	Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.	Post-intervention (2 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.	Post-intervention (2 months)
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.	Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality.	Post-intervention (2 months)
Secondary	Change in Wake After Sleep Onset (WASO) from baseline to post-intervention	Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in body weight (kg) from baseline to post-intervention	Change in body weight (kg) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in fat mass (kg) from baseline to post-intervention	Change in fat mass (kg) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in mean blood pressure (mm HG) from baseline to post-intervention	Change in mean blood pressure (mm HG) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in plasma glucose (mg/dL) from baseline to post-intervention	Change in plasma glucose (mg/dL) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in total cholesterol (mg/dL) from baseline to post-intervention	Change in total cholesterol (mg/dL) from baseline to post-intervention	Post-intervention (2 months)
Secondary	Change in total triglycerides (mg/dL) from baseline to post-intervention	Change in total triglycerides (mg/dL) from baseline to post-intervention	Post-intervention (2 months)