The Effect of Continuous Positive Airway Therapy on the Blood Pressure in Sleepy vs Non-sleepy Patients With Obstructive Sleep Apnea

NCT07497412 | Active Not Recruiting DMC

• 2 other identifiers: ANDANTE 17/12/2025MRA-25/26-53856
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnoea (OSA) is one of the most common noncommunicable types of disease, it affects about 1 billion people across the world. Left untreated, it causes apnoeas and hypopnoeas to fragment sleep, with frequent arousal from sleep and intermittent hypoxia associated with increased work of breathing. Frequently, it leads to excessive daytime sleepiness, as measured subjectively by the Epworth Sleepiness Scale, or, objectively, by the multiple sleep latency test (MSLT) or the maintenance of wakefulness test (MWT). OSA can lead to sustained high sympathetic tone at night, which in the long-term may impact on the cardiovascular risk. The investigators hypothesised that any primary airway therapeutic effect on the cardiovascular system, as measured by the blood pressure, in patients with OSA will differ dependent on whether subjects are excessively sleepy, or remain so when treated. Hypothesis

1. 1.Office blood pressure (SBP, DBP) responses to CPAP in patients with OSA who are excessively sleepy (ESS\>10) at baseline vs non-sleepy patients at baseline.
2. 2.24-hour BP data (SBP, DBP, dipping, nocturnal and daytime) in sleepy patients in response to CPAP vs non-sleepy patients.
3. 3.Adherence to treatment in sleepy patients may be different to non-sleepy patients and the observed effect effects will be adjusted in a secondary analysis according to available adherence data and follow up time.

Conditions

Obstructive Sleep Apnea

Keywords

cpap; continuous positive airway pressure; blood pressure; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Office blood pressure

  Office blood pressure measurements (systolic, diastolic in mmHg)

  through study completion, an average of 3months

Secondary Outcomes (2)

• 24 hours blood pressure

  through study completion, an average of 3months

• Nocturnal blood pressure dipping pattern

  through study completion, an average of 3months

Other Outcomes (2)

• Change in Epworth Sleepiness Scale associated with blood pressure changes (office, systolic / diastolic); minimal score 0, maximal score 24 points; higher scores indicate more severe sleepiness

  through study completion, an average of 3months

• Adherence to treatment

  through study completion, an average of 3months

Study Arms (2)

Sleepy patients with OSA

Patients with obstructive sleep apnea who are excessively sleepy, as measured by the Epworth Sleepiness Scale (ESS) \> 10 points

Device: Primary airway therapy (e.g., CPAP); Other: Control arm

Non-sleepy patients with OSA

Patients with obstructive sleep apnea who are not excessively sleepy, as measured by the Epworth Sleepiness Scale (ESS) \<= 10 points

Device: Primary airway therapy (e.g., CPAP); Other: Control arm

Interventions

Primary airway therapy (e.g., CPAP) DEVICE

Treatment to restore upper airway patency in the asleep patient with OSA (e.g., CPAP)

Non-sleepy patients with OSA; Sleepy patients with OSA

Control arm OTHER

Control arm included in the randomised controlled trials of the ANDANTE database

Non-sleepy patients with OSA; Sleepy patients with OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with OSA who were randomised in an interventional trial to treat the condition using primary airway therapy (e.g., CPAP) in a randomised controlled trial (included in the ANDANTE database, Pengo M, Eur Resp J 2025)

You may qualify if:

• Data for the individual patient data (IPD) meta-analysis, as published in the ANDANTE database (Pengo et al, European Respiratory Journal 2025)
• Patient with OSA (apnoea hypopnea index, AHI \> 5/hour)
• age \> 18 years

You may not qualify if:

• Not included in a randomised controlled trial to treat OSA
• not included in the ANDANTE database

Sponsors & Collaborators

• King's College London: lead
• University of Milan-Bocca: collaborator
• University of Grenoble-Alpes: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Pengo MF, Schwarz EI, Barbe F, Cistulli PA, Drager LF, Fava C, Fuchs FD, Ip MSM, Loffler KA, Lui MMS, Martinez-Garcia MA, McEvoy D, Peker Y, Phillips CL, Quinnell T, Soranna D, Steier J, Stradling JR, Zambon A, Parati G; ANDANTE collaborators. Effect of CPAP therapy on blood pressure in patients with obstructive sleep apnoea: a worldwide individual patient data meta-analysis. Eur Respir J. 2025 Jan 2;65(1):2400837. doi: 10.1183/13993003.00837-2024. Print 2025 Jan.

  PMID: 39401854 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jean-Louis Pepin, PhD

  University of Grenoble-Alpes

  STUDY CHAIR

• Carolina Lombardi, PhD

  University of Milan-Bocca

  PRINCIPAL INVESTIGATOR

• Miquel Serna Pascual, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Antonella Zambon, PhD

  University of Milan-Bocca

  STUDY DIRECTOR

• Davide Soranna

  University of Milan-Bocca

  PRINCIPAL INVESTIGATOR

• Joerg Steier, PhD

  King's College London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)