The headline endpoint in a sleep apnea trial comes from an overnight study that someone else scored, the symptom endpoints come from the participant’s phone, and the adherence number comes from a device. Capture keeps the sleep-study results, questionnaires, device-use data and safety events together on one record with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Scored by central reader
Study type
SSTYPERecording time
RECHRAHI, 4% hypopnea rule
AHI4Oxygen desaturation index, 4%
ODI4Lowest oxygen saturation
SPO2MINStudy quality
QUALWhat an obstructive sleep apnea trial needs from its EDC
The study data
Obstructive sleep apnea trials fall into two families. Device and procedure trials compare positive airway pressure, mandibular advancement devices, hypoglossal nerve stimulation, surgery or position therapy, and are often unblinded or sham-controlled. Drug and behavioural trials (weight loss, exercise, medicines aimed at airway muscle tone or arousal) usually run a placebo-controlled parallel or crossover design. Both depend on a baseline sleep study to confirm the diagnosis, with an apnea-hypopnea index of 5 or more events per hour a common entry threshold and bands such as 5 to 14 (mild), 15 to 30 (moderate) and above 30 (severe) used to stratify.
The primary endpoint in recent drug protocols is the change in AHI using a 4% hypopnea rule, with the oxygen desaturation index and an AHI that counts 3% desaturations or arousals reported as secondary or supportive. These are protocol and scoring-manual decisions and they change the numbers, so a good form stores the study type (in-lab polysomnography or home sleep apnea test), recording time, each index with its rule in the variable name, lowest oxygen saturation and a quality flag. Do not overwrite a failed study; enter the repeat as a new record and let the reason for any change sit in the audit trail.
This page is the apnea-specific companion to EDC for sleep disorder clinical trials, which covers insomnia and general sleep medicine with a nightly diary. Here the focus is the sleep study, the airway device and the sleepiness and cardiometabolic outcomes that define OSA research.
Raw polysomnography and home-test signals are large files held in the scoring software or by the central reader. Capture is not a signal archive. The eCRF holds the structured results the analysis needs, the identifier of the study so a reviewer can find the file, and the date. Agree the transfer format with the central reader in the data management plan, and decide whether results are entered by the site or imported by the study team from the reader’s report.
AHI, events per hour
18.6 / 60
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | AHI threshold, symptoms, BMI, airway exam, comorbidities, prior therapy | Eligibility form with a calculated BMI and edit checks |
| Sleep study | Study type, recording time, AHI and ODI with their rules, minimum saturation, quality | Visit eCRF form per study; repeat studies as new records |
| Sleepiness and sleep quality | Questionnaire items, total and date | Phone questionnaires such as the Epworth Sleepiness Scale template and PSQI template |
| Daily symptoms | Morning sleep diary, naps, device used last night | Phone diary based on the sleep diary template |
| Device use | Hours per night, nights used, mask or appliance problems | Repeating site form or study-team import; see medication adherence capture for the pattern |
| Cardiometabolic | Blood pressure, weight, waist, glucose, lipids | Vital signs and lab results forms |
| Allocation | Arm, stratified by severity band or BMI | Randomization in the same platform |
| Safety | Adverse events, device-related events, serious events | Adverse event form with severity, seriousness and causality as separate fields |
Capture records the data your protocol defines. Diagnosis, scoring rules and severity are decided by clinicians, scorers and the statistical plan.
Upload the protocol, let the AI draft the visits and forms for review, then run a practice participant through the sleep study, a sleepiness questionnaire and a device check on a real phone. Free sandbox.
Device adherence
In positive airway pressure trials, usage in hours per night is often an outcome in its own right, and the proportion of participants using the device for 4 hours or more per night is a frequent adherence definition. Registered trials differ: some take objective usage from the device’s memory card or modem, others rely on self-report. Decide the source, the period (last 7 nights, last 30 nights or since the previous visit) and how to treat nights with no data, and write the rule down before the first visit.
Capture does not connect to a CPAP machine or vendor cloud. What it can do is hold the numbers: a site form that records average nightly hours and nights used for the period, or a study-team import of the device report into the same record, with the source named in a field. A participant-reported morning item (“Did you use the device last night?”) is a separate, subjective measure and should be kept as one. Keep the two apart so the analysis can compare them. For wearable data that does sync natively, see EDC for wearable device studies.
Adherence is also a retention risk. Reminders, a visible completion window and a coordinator view of who has not responded keep short questionnaires on schedule; see ePRO compliance and reminders.
Participants ≥ 4 h/night
71%
Median hours
5.3
No download this period
3
Two device downloads missing
Safety and blinding
Safety in sleep apnea trials includes the usual adverse event list plus device-specific events: skin irritation from masks, dry mouth, jaw or tooth discomfort with oral appliances, procedure-related events with surgery or implants, and for drugs whatever the compound brings. Keep onset, severity, seriousness, relationship and action taken as separate answers; the AE seriousness decision tree and AE causality assessment page explain how.
Many device trials cannot blind the participant. They can still blind the people who score outcomes. Blinded roles in Capture never receive treatment-arm values, enforced by masked database views and row-level security rather than by the interface alone, which lets a central scorer or an outcome assessor work without seeing the allocation. For a sham-controlled design, record the allocation only in the randomization module and keep device serial numbers on a restricted form.
Build sequence
A realistic order of work for a sponsor, device company or investigator-initiated team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
One form with study type, recording time, each index with its scoring rule, minimum saturation and a quality flag, plus range checks on every value.
Sleepiness, sleep quality and the morning diary with completion windows and reminders; licences for named instruments stay with your study documents.
Average hours, nights used and source of the figure; adverse events with device-related events as a category.
Run practice participants through a failed study, a missed download and a device problem, approve the forms and start the paid live phase when real participants enrol.
Consent, sites and exports
Participants sign on screen after an email one-time code and the investigator countersigns with password re-authentication; see eConsent for clinical trials. Sleep centres running multi-site studies use QR-code enrolment, site-level numbering and by-site exports (multi-site clinical trial management). Exports come as CSV or Excel with an automatic data dictionary and, for submissions, SDTM datasets as SAS XPT with Define-XML (SDTM export).
If your question is about the questionnaires rather than the apnea indices, the Epworth Sleepiness Scale and PSQI pages show how a score, bands and item structure sit in a form. Instruments are named, never reproduced here.
Yes, as structured number fields with units and range checks. Store the scoring rule with each value, for example 3% or 4%, because the rule changes the result.
No. Capture does not claim a CPAP or sleep-device integration. Device-use hours can be entered by the site or imported by the study team into the same record, with the source recorded.
You can build a phone questionnaire that opens from a secure link, with reminders. Capture does not supply licensed wording; your team confirms the terms with the rights holder and files them with the study documents.
Blinded roles never receive treatment-arm values; this is enforced by masked database views and row-level security, so a scorer or outcome assessor can enter or review results without seeing the arm.
Record it as a new entry with a quality flag on the original. Changes to a field show old value, new value, user, time and reason in the audit trail.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for sleep disorder clinical trials
Insomnia and general sleep medicine with a nightly diary.
Epworth Sleepiness Scale eCRF template
Score and band structure for sleepiness.
Sleep diary template
A nightly or morning diary to copy and adapt.
EDC for medical device clinical trials
Device studies and deficiencies.
Capture ePRO
Phone questionnaires, reminders and completion windows.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.