Clinical trial NCT03851653: Lifestyle Intervention for OSA in Adults
Official title: Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
weight loss
lifestyle intervention
continuous positive airway pressure
OSA
CPAP
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 89
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
timeFrame: Post-intervention (2 months)
Secondary outcomes:
measure: Change in oxygen desaturation index (ODI) from baseline to post-intervention.
timeFrame: Post-intervention (2 months)
measure: Change in oxygen saturation (SaO2) mean from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in oxygen saturation (SaO2) nadir from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in sleep efficiency from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in light sleep (N1 and N2 stages) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in deep sleep (N3 stage) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in rapid eye movement (REM) sleep from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
timeFrame: Post-intervention (2 months)
measure: Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
timeFrame: Post-intervention (2 months)
measure: Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.
timeFrame: Post-intervention (2 months)
measure: Change in Wake After Sleep Onset (WASO) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in body weight (kg) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in fat mass (kg) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in mean blood pressure (mm HG) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in plasma glucose (mg/dL) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in total cholesterol (mg/dL) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in total triglycerides (mg/dL) from baseline to post-intervention
timeFrame: Post-intervention (2 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
affiliation: Universidad de Granada
name: Jonatan R. Ruiz, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Granada
name: Almudena Carneiro-Barrera, MD
role: PRINCIPAL_INVESTIGATOR
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: 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: 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.
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.
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.
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: Carneiro-Barrera A, Amaro-Gahete FJ, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Tinahones FJ, Ruiz JR. Effect of a Weight Loss and Lifestyle Intervention on Dietary Behavior in Men with Obstructive Sleep Apnea: The INTERAPNEA Trial. Nutrients. 2022 Jun 30;14(13):2731. doi: 10.3390/nu14132731.
citation: Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.