NCT03851653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

February 20, 2019

Last Update Submit

January 9, 2021

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaweight losslifestyle interventioncontinuous positive airway pressureOSACPAP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Change in oxygen desaturation index (ODI) from baseline to post-intervention.

    Post-intervention (2 months)

  • Change in oxygen saturation (SaO2) mean from baseline to post-intervention

    Post-intervention (2 months)

  • Change in oxygen saturation (SaO2) nadir from baseline to post-intervention

    Post-intervention (2 months)

  • Change in sleep efficiency from baseline to post-intervention

    Post-intervention (2 months)

  • Change in light sleep (N1 and N2 stages) from baseline to post-intervention

    Post-intervention (2 months)

  • +13 more secondary outcomes

Study Arms (2)

Lifestyle Intervention Group (LIG)

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).

Interventions

Lifestyle InterventionBEHAVIORAL

Cognitive-behavioural intervention for weight loss and lifestyle change

Lifestyle Intervention Group (LIG)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18011, Spain

Location

Related Publications (11)

  • 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.

    PMID: 30609450BACKGROUND

  • 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.

    PMID: 19201228BACKGROUND

  • 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.

    PMID: 27296826BACKGROUND

  • 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.

    PMID: 28215266BACKGROUND

  • 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.

    PMID: 25976943BACKGROUND

  • 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.

    PMID: 31540168BACKGROUND

  • Vazquez-Lorente H, Herrera-Quintana L, Ruiz JR, Amaro-Gahete FJ, Carneiro-Barrera A. Impact of weight loss and lifestyle intervention on vitamin D in men with obstructive sleep apnea: The INTERAPNEA trial. Sleep Med. 2025 Apr;128:37-45. doi: 10.1016/j.sleep.2025.01.011. Epub 2025 Jan 21.

    PMID: 40023509DERIVED

  • Carneiro-Barrera A, Amaro-Gahete FJ, Lucas JF, Saez-Roca G, Martin-Carrasco C, Lavie CJ, Ruiz JR. Weight loss and lifestyle intervention for cardiorespiratory fitness in obstructive sleep apnea: The INTERAPNEA trial. Psychol Sport Exerc. 2024 May;72:102614. doi: 10.1016/j.psychsport.2024.102614. Epub 2024 Feb 17.

    PMID: 38369267DERIVED

  • Carneiro-Barrera A, Amaro-Gahete FJ, Saez-Roca G, Martin-Carrasco C, Palmeira AL, Ruiz JR. Interdisciplinary Weight Loss and Lifestyle Intervention for Daily Functioning and Psychiatric Symptoms in Obstructive Sleep Apnea: The INTERAPNEA Randomized Clinical Trial. J Clin Psychiatry. 2023 Jun 12;84(4):22m14502. doi: 10.4088/JCP.22m14502.

    PMID: 37339363DERIVED

  • 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.

    PMID: 35807913DERIVED

  • 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.

    PMID: 35452108DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveWeight Loss

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gualberto Buela-Casal, PhD

    Universidad de Granada

    STUDY DIRECTOR

  • Jonatan R. Ruiz, PhD

    Universidad de Granada

    STUDY DIRECTOR

  • Almudena Carneiro-Barrera, MD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research Academic Staff

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

April 1, 2019

Primary Completion

October 13, 2020

Study Completion

November 30, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

All individual participant data (IPD) that underlie results in a publication

Time Frame
After publication

Locations

ES(1)