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What Causes Sleep Apnoea to Vary Between Nights? A Multi-Night Detailed Study

In-Lab Sleep Monitoring to analyse the Mechanistic Factors and Endotypes that Drive Night-to-Night Variability (N2NV) in Obstructive Sleep Apnoea

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000299303
Enrollment
48
Registered
2026-03-10
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with highly variable sleep apnoea from night to night have different underlying breathing and airway characteristics compared to people whose sleep apnoea is more stable. Detailed in-lab measurements across several nights can explain why sleep apnoea severity changes so much for some people but not others.

Interventions

Participants with high standard deviation (>66%) in apnoea hypopnoea index (AHI) based on 30 nights of at-home assessment prior to the study. Consent + Baseline Data [~2 hours]: Once the participant signs consents, Each participant will first be assessed for their height, weight, facial dimensions (Interzygomatic distance, inter gonion distance, ala-tragus distance, and bilateral gonion to menton distance), mandibular range of motion, neck length and circumference, and Mallampati score. They wi

Participants with high standard deviation (>66%) in apnoea hypopnoea index (AHI) based on 30 nights of at-home assessment prior to the study. Consent + Baseline Data [~2 hours]: Once the participant signs consents, Each participant will first be assessed for their height, weight, facial dimensions (Interzygomatic distance, inter gonion distance, ala-tragus distance, and bilateral gonion to menton distance), mandibular range of motion, neck length and circumference, and Mallampati score. They will then be asked to complete a Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Temporomandibular Joint Pain Screener, Research Diagnostic Criteria questionnaire for TMD, and Steigerwald and Maher TMJ Disability Index. Standard Diagnostic Sleep Study (48 participants, nights 1 to 3, ~8h per night) During these nights, the following effect modifiers will be assessed: • Polysomnography (PSG): to assess sleep stages, AHI, arousal thresholds, sleep hypoxemia, and muscle function (endotypes). • Body position: using under-mattress sleep analyser. • Neck extension and flexion: assessed using an accelerometer motion tracking system and real-time camera-based monitoring continuously recording audio-visual data of head, neck, body, and jaw positions. • Jaw position: assessed by both accelerometer/magnetometer tracking and real-time camera-based monitoring of jaw movement during sleep. • Jaw muscle activity: involuntary jaw activity will be assessed using surface EMG of the masseter muscles. Extended Respiratory Physiology Study (~24 participants, nights 4 to 6, ~8h per night) Participants will be fitted with a nasal mask with pneumotachograph, pressure-tipped catheters (epiglottic and choanal), and mask pressure transducer, but this time participants will be asked to sleep with this equipment to upper-airway physiology during sleep. • Sleep collapsibility analyses: After topical decongestant and anaesthetic spray, a nasal catheter will be inserted to measure epiglottic pressure. A nasal mask fitted with a calibrated airflow sensor will be used. Mouth will be taped to ensure nasal breathing and can be easily replaced as required. Epiglottic pressures will be analysed to assess breathing effort, work of breathing, and distinctions between effective and ineffective snoring, using established analytical methods. Inspiratory and expiratory flow–time curves will be evaluated to detect the site of collapse (epiglottic, retrolingual, or palatal) for each breath exhibiting flow limitation. CPAP Manipulation (Drop) Protocol (Night 7 only, ~8 hours): In addition to all the tasks performed in Nights 4 to 6, o Participants will undergo active and passive Pcrit assessments during staged gradual CPAP reductions (10 cmH2O to 2 cmH2O). o The first few breaths after CPAP drop will be analysed for anatomical stability. o The following breaths will be analysed for neuromuscular compensation.

Sponsors

Flinders University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligibility will require placement in either the top or bottom tertile of AHI variability (i.e., 66% based on AHI standard deviation), with a mean AHI less than 30 indicating low OSA severity and greater than or equal to 30 indicating high severity. Participants who take part in an existing Flinders University cohort observational study, which has ethical approval (SALHN Ethics approval LR/SAC/24/045.24) will be invited to participate in this physiology study. Only participants who are located in Adelaide (the other site being located in Sydney) will be contacted. This is because all participants in the existing cohort undergo prolonged multi-night at home sleep monitoring (at least 30 nights required) which enables us to recruit participants with the right characteristics of OSA variability as well as match for age, gender and BMI. Eligibility may be determined using convenience sampling with age and BMI matching, keeping in mind that the ranges to which is considered a match might be broadened in the event where enough participants are not identified.

Exclusion criteria

Participants undergoing the 30 nights of at-home study who do not fall within the 66% tertiles based on AHI standard deviation

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 20, 2026