Lifestyle Intervention for OSA in Adults

• ClinicalTrials.gov Identifier: NCT03851653
• Recruitment Status: Completed
• First Posted: February 22, 2019
• Last Update Posted: January 12, 2021
• Sponsor: Universidad de Granada
• Information provided by (Responsible Party): Almudena Carneiro Barrera, Universidad de Granada

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Behavioral: Lifestyle Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: October 13, 2020
• Actual Study Completion Date: November 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lifestyle Intervention Group (LIG); Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP.	Behavioral: Lifestyle Intervention; Cognitive-behavioural intervention for weight loss and lifestyle change
No Intervention: Control group; Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).

Outcome Measures

Primary Outcome Measures :

1. Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention. [ Time Frame: Post-intervention (2 months) ]
   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.

Secondary Outcome Measures :

1. Change in oxygen desaturation index (ODI) from baseline to post-intervention. [ Time Frame: Post-intervention (2 months) ]
   Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
2. Change in oxygen saturation (SaO2) mean from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Change in the average of oxygen saturation from baseline to post-intervention
3. Change in oxygen saturation (SaO2) nadir from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Minimum oxygen saturation from baseline to post-intervention
4. Change in sleep efficiency from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Change in the total sleep time/total time in bed from baseline to post-intervention
5. Change in light sleep (N1 and N2 stages) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention
6. Change in deep sleep (N3 stage) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention
7. Change in rapid eye movement (REM) sleep from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
   Change in the percentage of REM sleep from baseline to post-intervention
8. Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention. [ Time Frame: Post-intervention (2 months) ]
   Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
9. Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention. [ Time Frame: Post-intervention (2 months) ]
   Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
10. Change in excessive daytime sleepiness (EDS) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    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.
11. Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. [ Time Frame: Post-intervention (2 months) ]
    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.
12. Change in Wake After Sleep Onset (WASO) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention
13. Change in body weight (kg) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in body weight (kg) from baseline to post-intervention
14. Change in fat mass (kg) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in fat mass (kg) from baseline to post-intervention
15. Change in mean blood pressure (mm HG) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in mean blood pressure (mm HG) from baseline to post-intervention
16. Change in plasma glucose (mg/dL) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in plasma glucose (mg/dL) from baseline to post-intervention
17. Change in total cholesterol (mg/dL) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in total cholesterol (mg/dL) from baseline to post-intervention
18. Change in total triglycerides (mg/dL) from baseline to post-intervention [ Time Frame: Post-intervention (2 months) ]
    Change in total triglycerides (mg/dL) from baseline to post-intervention

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Spain

University of Granada

Granada, Spain, 18011

Sponsors and Collaborators

Universidad de Granada

Investigators

• Study Director: Gualberto Buela-Casal, PhD; Universidad de Granada
• Study Director: Jonatan R. Ruiz, PhD; Universidad de Granada
• Principal Investigator: Almudena Carneiro-Barrera, MD; Universidad de Granada

More Information

Publications:

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Almudena Carneiro Barrera, Teaching and Research Academic Staff, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT03851653
• Other Study ID Numbers: INTERAPNEA-2019
• First Posted: February 22, 2019
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All individual participant data (IPD) that underlie results in a publication
• Time Frame: After publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Almudena Carneiro Barrera, Universidad de Granada:

obstructive sleep apnea; weight loss; lifestyle intervention; continuous positive airway pressure; OSA; CPAP

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases