Raising the head of the bed to 30 degrees for adults with snoring and obstructive sleep apnoea

ISRCTN ISRCTN55880336
DOI https://doi.org/10.1186/ISRCTN55880336
Sponsor protocol number Keeson-Softide-PSG-MC-001
Sponsor Keeson Technology Corporation
Funder Keeson Technology Corporation
Submission date
18/08/2026
Registration date
18/08/2026
Last edited
18/08/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Obstructive sleep apnoea (OSA) causes repeated pauses in breathing during sleep and loud snoring. Sleeping position affects how bad it is. This study tested whether raising the head end of an adjustable bed to 30 degrees reduces breathing pauses and snoring, and which patients benefit most.

Who can participate?
Adults aged 18 years and over with suspected or confirmed OSA

What does the study involve?
Each person had two overnight sleep studies on the same bed — one lying flat and one with the head of the bed raised to 30 degrees — in a random order, and the results were compared.

Possible benefits and risks
Possible benefit: fewer breathing pauses and less snoring on the raised night. Head-of-bed elevation is low-risk.

Where is the study run from?
Keeson Technology Corporation (China)

When did the study run?
November 2021 to December 2022

Who is funding the study?
Keeson Technology Corporation (China)

Who is the main contact?
Dr Yuan Dong, arthur.dong@keeson.com

Contact information

Dr Yuan Dong
Public, Scientific, Principal investigator

1508 Xiushui Avenue
Jiaxing
314000
China

ORCiD logo 0009-0000-4327-5723
+86 (0)138 1732 4995
arthur.dong@keeson.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentCrossover
PurposeTreatment
Scientific titleEfficacy and safety of 30° head-of-bed elevation delivered by an electric smart-bed, versus a flat observation night, on the apnoea–hypopnoea index and whole-night snoring burden in adults with obstructive sleep apnoea: a multicentre randomised-order crossover study (HOBE-OSA)
Study acronymHOBE-OSA
Study objectives 1. To evaluate the efficacy of fixed 30° head-of-bed elevation on the apnoea–hypopnoea index (AHI) and whole-night snoring burden in adults with obstructive sleep apnoea
2. To identify the beneficiaries — which patients benefit and by how much, analysed by baseline severity and positional phenotype
3. To monitor safety (treatment-emergent adverse events on the intervention night). Reporting follows the SPIRIT/CONSORT guidance for crossover trials
Ethics approval(s)

Approved 30/10/2021, Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (732 Jiayuguan West Road, Lanzhou, 730020, China; +86 (0)931 863 5928; arthurmyway@qq.com), ref: [2021]35

Health condition(s) or problem(s) studiedObstructive sleep apnoea and habitual snoring
InterventionSoftide Smart-Bed prototype — an adjustable ("smart") bed combining electric actuators with non-contact physiological sensing (Keeson Technology Corporation; developed 2020–2021; not a marketed device at the time of the study).

Within-patient randomised-order crossover. Each participant underwent two whole-night attended polysomnograms on the same study adjustable bed: (i) an observation night in the flat (0°) configuration (the within-patient control), and (ii) an intervention night with the upper half of the bed raised to a fixed 30° for the whole night (adaptive/closed-loop features disabled). The two nights were usually consecutive (median inter-night gap 1 night). Night order was assigned 1:1 from a computer-generated random sequence prepared centrally by the sponsor and disclosed to the site immediately before each participant's first study night. One centre (Qinhuangdao, n = 10) did not randomise (all observation-first) and is handled by a pre-specified sensitivity analysis.
Intervention typeDevice
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Softide Smart-Bed prototype
Primary outcome measure(s)
  1. Paired within-patient change in total apnoea–hypopnoea index (AHI) measured using two whole-night polysomnograms at intervention night and observation night
  2. Paired within-patient change in whole-night snoring burden (co-primary) measured using two whole-night acoustic recordings at intervention night and observation night
Key secondary outcome measure(s)
  1. Paired within-patient change in Oxygen Desaturation Index 3% (ODI3) and Oxygen Desaturation Index 4% (ODI4) measured using two whole-night polysomnograms at intervention night and observation night
  2. Paired within-patient change in oxygen-desaturation morphology (duration/area/depth) measured using two whole-night polysomnograms at intervention night and observation night
  3. Paired within-patient change in SpO₂ summary statistics (mean/median/ variability) measured using two whole-night polysomnograms at intervention night and observation night
  4. Paired within-patient change in positional behaviour, ΔPHI = Δlog₂(supine/lateral minutes) measured using two whole-night polysomnograms at intervention night and observation night
  5. Paired within-patient change in positional physiology, ΔPSI = Δlog₂(supine/lateral AHI), measured using two whole-night polysomnograms at intervention night and observation night
  6. Safety measured using treatment-emergent adverse events at on and after the intervention night
Completion date31/12/2022

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit99 Years
SexAll
Target sample size at registration60
Total final enrolment63
Key inclusion criteria1. Adults aged 18 years or older, male or female
2. Clinically suspected or polysomnography-confirmed obstructive sleep apnoea (no minimum apnoea–hypopnoea index [AHI] required for enrolment)
3. Able to undergo two whole-night polysomnograms on the study adjustable bed
4. Written informed consent
Key exclusion criteria1. Predominantly central sleep apnoea or another primary sleep disorder
2. Current obstructive sleep apnea (OSA) treatment that could confound posture/airway effects (continuous positive airway pressure [CPAP], oral appliance, or prior upper-airway surgery)
3. Unstable cardiopulmonary or neuromuscular disease, or any contraindication to head-of-bed elevation
4. Pregnancy
5. Inability to complete both study nights or to comply with study procedures
Date of first enrolment01/11/2021
Date of final enrolment31/12/2022

Locations

Countries of recruitment

  • China

Study participating centres

Affiliated Hospital of Gansu University of Chinese Medicine
732 Jiayuguan West Road
Lanzhou
730020
China
Qinhuangdao Haigang Hospital
131 Wenhua Road
Qinhuangdao
066099
China
Huai'an Third People's Hospital
272 Huaihai West Road
Huai'an
223023
China
Bayannur Municipal Hospital
98 Wulanbuhe Road
Bayannur
015000
China
Suzhou Guangji Hospital
11 Guangqian Road
Suzhou
215003
China

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing planThe datasets generated and/or analysed during the current study will be available upon request from Yuan Dong (arthur.dong@keeson.com). De-identified night-level data (posture, AHI, sleep-stage minutes, oxygen and snoring metrics) and the complete analysis/figure code are available on reasonable request. De-identified raw polysomnography (EDF) and whole-night snoring audio are retained and can be shared for independent re-scoring/audit, subject to participant-privacy and institutional data-sharing policy. Participants gave written informed consent; data are anonymised before sharing.

Editorial Notes

18/08/2026: Study's existence confirmed by the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine.

BMC - Part of Springer Nature Springer Nature